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DOCKETS ENTERED on August 23, 2000 TABLE OF CONTENTS Hyper links are part of the Docket title - not all dockets/documents are linked. NOTE: Documents received by the Dockets Management Branch "MAY" be posted on the Internet. PLEASE DO NOT include personal identifying information, i.e. date of birth, social security number, etc., in your correspondence. |
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94S-0120 510K Substantially Equivalent List * 97N-0436 Methods informing consumers of contents of bottle water * 97P-0078 Recognized the Term "Soymilk" as the Established Common of U * 97P-0150 Amend the Advisory Committee Committee Regulations * 98F-0165 safe use of ionizing radition for reduction of salmonella * 98P-0151 Introduction Of Downed Cattle Into The Food Supply * 98P-1018 Carboard cutter boxes in violation of 1997 FDA FOOD CODE * 99P-0033 Combat the spread of transmissible spongiform encephalopathy * 99P-1340 Declared Eternity eau de Parfum Misbranded * 99P-3030 Health Claim: Saw Palmetto & Benign Prostatic Hyperplasia * 99P-4613 Revoke the Regulation That Approved Posilac * 00D-1307 Parathyroid Hormone/Prevention & Treatment of Osteoporosis * 00D-1318 Chronic Cutaneous Ulcer/Burn Wounds--Products for Treatment * 00N-0504 Egg Safety Action Plan * 00N-1351 Use of the Term "Fresh" for Foods Processed w/Alt Nonthermal * 00N-1394 Medical Devices; CLIA Waiver Criteria Public Workshop * 00P-0804 FD&C Yellow #5 & FD&C Blue #1 Labeling * 00P-1211 Establish Mandatory Pre-Market Safety Testing for GE Foods * 00P-1265 Performance standard for electrode lead wires & patient cabl * 00P-1470 ANDA 75-880 for 6%and10% PremaSol-sulfite-free (Amino Acid) * |
LST 97 July 2000 510k Monthly Vol#: 23
97N-0436 Methods informing consumers of contents of bottle water
EMC 62 P Delmore Vol#: 7
97P-0078 Recognized the Term "Soymilk" as Established Common of U
C 137 Cumberland Dairy Vol#: 2
97P-0150 Amend the Advisory Committee Committee Regulations
PDN 1 HF-11
to Baker & Daniels Vol#: 1
98D-0362 Stability Testing of Drug Substances and Drug Products
C 73 Pharm Research and Manuf of America Vol#: 5
98F-0165 safe use of ionizing radition for reduction of salmonella
HER 5 Society for Animal Protective Legislatio Vol#: 1
OB 16 Purdue University Vol#: 1
98P-0151 Introduction Of Downed Cattle Into The Food Supply
C 2317 V Edmer Vol#: 67
C 2318 V Perry Vol#: 67
C 2319 S Young Vol#: 67
C 2320 S Shoss Vol#: 67
98P-1018 Carboard cutter boxes in violation of 1997 FDA FOOD CODE
PDN 1 HFC-1 Kenkut Products Inc Vol#: 1
99P-0033 Combat the spread of transmissible spongiform encephalopathy
C 366 J Kent Vol#: 9
C 367 E McNeill Vol#: 9
C 368 R Doidge Vol#: 9
C 369 L Rollins Vol#: 9
C 370 R Taber Vol#: 9
C 371 K Mills Vol#: 9
C 372 R Kopetzky Vol#: 9
C 373 M McNamara Vol#: 9
C 374 B Sirmans Vol#: 9
C 375 S M Horton Vol#: 9
C 376 M Hass Vol#: 9
C 377 P Brant Vol#: 9
C 378 J Setzer Vol#: 9
C 379 J Byron Vol#: 9
C 380 S Lybrand Vol#: 9
99P-1340 Declared Eternity eau de Parfum Misbranded
EMC 159 A Tully Vol#: 16
99P-2630 Establish a Daily Value for "added sugars"
EC 15 self Vol#: 1
99P-3030 Health Claim: Saw Palmetto & Benign Prostatic Hyperplasia
C 199 M Moore Vol#: 8
99P-4613 Revoke the Regulation That Approved Posilac
C 1339 J Wolfe Vol#: 43
C 1340 A Alba Vol#: 43
EMC 2325 S McClelland Vol#: 43
EMC 2326 L Marquis Vol#: 43
00D-1307 Parathyroid Hormone/Prevention & Treatment of Osteoporosis
C 10 University of Pittsburgh School of Medic Vol#: 2
00D-1318 Chronic Cutaneous Ulcer/Burn Wounds--Products for Treatment
00H-1242 Civil Money Penalty;Laser Vision Centers Inc. et al
RMO 1 Laservision Centers Inc. Vol#: 1
RMO 2 GCF-1 Vol#: 1
00N-0504 Egg Safety Action Plan
EMC 192 J Lee Vol#: 6
EMC 193 J Lee Vol#: 6
EMC 194 A Shindler Vol#: 6
EMC 195 T Elwing Vol#: 6
EMC 196 Senior Citizens for Humane Legislation Vol#: 6
EMC 197 E Mass Vol#: 6
EMC 198 B Sundberg Vol#: 6
EMC 199 H Freeman Vol#: 6
EMC 200 J Coe Vol#: 6
EMC 201 J Trombini Vol#: 6
EMC 202 M Cohen Vol#: 6
EMC 203 R Mannich Vol#: 6
EMC 204 K Bartell Vol#: 6
EMC 205 K Hayes Vol#: 6
EMC 206 A Tirapani Vol#: 6
EMC 207 J Janicki Vol#: 6
EMC 208 R Blanchard Vol#: 6
EMC 209 C McGehee Vol#: 6
EMC 210 K Malmquist Vol#: 6
EMC 211 K MacDonald Vol#: 6
EMC 213 C Kistner Vol#: 6
EMC 214 C Tiano Vol#: 6
EMC 215 M Pattarelli Vol#: 6
EMC 216
Illinois Humane Political Action Committ Vol#: 6
00N-1200 Dietary Supplements Containing Ephedrine Alkaloids
C 18 N Michal Vol#: 64
EMC 7 J Johnson Vol#: 62
EMC 8 G Delfino Vol#: 62
EMC 9 C Dina Vol#: 62
EMC 10 G Smoak Vol#: 62
EMC 11 W Ramsey Vol#: 62
EMC 12 W Ebbs Vol#: 64
EMC 13 Irons1238 Vol#: 64
EMC 14 MOMO 1284 Vol#: 64
00N-1256 Over-the-Counter Drug Products;Public Hearing
CH 413 K Rekkas Vol#: 17
CH 414 R Risse Vol#: 17
CH 415 D Gall Vol#: 17
CH 416 R Gunsett Vol#: 17
CH 417 I Scott Vol#: 17
CH 418 J von Reyn Vol#: 17
CH 419 J Krain Vol#: 17
CH 420 J DeShazo Vol#: 17
CH 421 C Larock Vol#: 17
CH 422 L Jones Vol#: 17
CH 423 K Reilly Vol#: 17
CH 424 S Ballhorn Vol#: 17
CH 425 D Ambrose, RN Vol#: 17
CH 426 J Rod Vol#: 17
CH 427 L Smack Vol#: 17
CH 428 E Mayes Vol#: 17
CH 429 R Kenton Vol#: 17
CH 430 B Goodman, PhD Vol#: 17
CH 431 B Donovan Vol#: 17
CH 432 E Feren Vol#: 17
CH 433 J Reeder Vol#: 17
CH 434 Angsim Vol#: 17
CH 435 L von Buelow Vol#: 17
CH 436 Mr and Mrs R Crone Vol#: 17
CH 437 A Messinger Vol#: 17
CH 438 D Kelly Vol#: 17
CH 439 P Otondo Vol#: 17
CH 440 M Stoll Vol#: 17
CH 441 K McPherson, MS Vol#: 17
CH 442 S Auman, RN Vol#: 17
CH 443 B O'Brien Vol#: 17
CH 444 C Feldman Vol#: 17
CH 445 G. Abbott Vol#: 17
CH 446 C Peck Vol#: 17
CH 447 H Emerson, RN Vol#: 17
CH 448 K Lynn Vol#: 17
CH 449 L Huddleston Vol#: 17
CH 450 N Carpenter Vol#: 17
CH 451 M Jean Vol#: 17
CH 452 M Barrows Vol#: 17
CH 453 K Anthony Vol#: 17
CH 454 E Trubert Vol#: 17
CH 455 S Cronin Vol#: 17
CH 456 B Voorhies Vol#: 17
CH 457 E Downs Vol#: 17
CH 458 K Andry Vol#: 17
CH 459 Babyjetta Vol#: 17
CH 460 B Wall Vol#: 17
CH 461 hotchkiss Vol#: 17
CH 462 M Sacoff Vol#: 17
CH 463 P Lievow Vol#: 17
CH 464 Haarmann & Reimer Vol#: 17
CH 465 Program for Appropriate Tech in Health Vol#: 17
EC 471 J Scudiere Vol#: 14
EC 472 J Nannarone Vol#: 14
EC 473 National Abortion and Reproductive Actio Vol#: 14
EC 474 J Kottke Vol#: 14
EC 475 L Nelms Vol#: 14
EC 476 California Family Health Council, Inc Vol#: 14
EC 477 C Wiesner Vol#: 14
EC 478 Seidenberg Law Office Vol#: 14
EC 479 NOW and individually Vol#: 14
EC 480 None Vol#: 14
EC 481 webslingerz Vol#: 14
EC 482 MSmith Vol#: 14
EC 483 d llorens Vol#: 14
EC 484 J Warburton Vol#: 14
EC 485 Memorial Health Center Vol#: 14
EC 486 United Methodist Women Vol#: 14
EC 487 C Hackman Vol#: 14
EC 488 j graham Vol#: 14
EC 489 L Hack Vol#: 14
EC 490 T Cook Vol#: 14
EC 491 S Sidhwaney Vol#: 14
EC 492 None Vol#: 14
EC 493 T Clauson Vol#: 14
EC 494 L Chandler Vol#: 14
EC 495 D Bachrach Vol#: 14
EC 496 L Mooey Vol#: 14
EC 497 M De Shazo Vol#: 14
EC 498 R Gossett Vol#: 14
EC 499 D Long Vol#: 14
EC 500 D Wilkie Vol#: 14
EC 501 C Reynolds Vol#: 14
SUP 2 ASEC Vol#: 18
00N-1351 Use of the Term "Fresh" for Foods Processed w/Alt Nonthermal
EC 35 D Boyar Vol#: 4
EC 36 self Vol#: 4
EC 37 University of Notre Dame Vol#: 4
EC 38 K Petersen Vol#: 4
EC 39 GRACE Vol#: 4
EC 40 Rochester/Genesee Valley Greens Vol#: 4
EC 41 International Fresh-cut Produce Associat Vol#: 4
EC 42 Vashon Island Growers Association Vol#: 4
EC 43 MYSELF Vol#: 4
EC 44 Aurora Vol#: 4
EC 45 Organic Consumers Association Vol#: 4
EC 46 Florida's Natural Growers Vol#: 4
EC 47 M Welch Vol#: 4
EC 48 Sun Orchard, Inc. Vol#: 4
00N-1357 FDA Concept Paper:Demonstrably Difficult to Compound Drugs
ANS 1 WOC2 to Sh Capps Vol#: 1
00N-1394 Medical Devices; CLIA Waiver Criteria Public Workshop
C 9 American Academy of Dermatology & Others Vol#: 1
00N-1460 Salmonella Enteritidis Research Public Meeting
NM 1 HFS-300 Vol#: 1
00P-0804 FD&C Yellow #5 & FD&C Blue #1 Labeling
PDN 1 HFC-1 TO T Crouthamel Vol#: 1
00P-1211 Establish Mandatory Pre-Market Safety Testing for GE Foods
EMC 1901 J Leong Vol#: 195
EMC 1902 S Spontak Vol#: 195
EMC 1903 K Grosz Vol#: 195
EMC 1904 M Roman Vol#: 195
EMC 1905 V Jackson Vol#: 195
EMC 1906 E Brown Vol#: 195
EMC 1907 A Caballero Vol#: 195
EMC 1908 J Burgess Vol#: 195
EMC 1909 L Newnham Vol#: 195
EMC 1910 B Fitzpatrick Vol#: 195
EMC 1911 L Dennis Vol#: 195
EMC 1912 T Wardell Vol#: 195
EMC 1913 R Parrish Vol#: 195
EMC 1914 I Lundquist Vol#: 195
EMC 1915 P Van Bloem Vol#: 195
EMC 1916 R Piccolo Vol#: 195
EMC 1917 Berman Vol#: 195
EMC 1918 G Primig Vol#: 195
EMC 1919 E Henderson Vol#: 195
EMC 1920 R. Rausch Vol#: 195
EMC 1921 C. Rausch Vol#: 195
EMC 1922 S Andersson Vol#: 195
EMC 1923 H Real Vol#: 195
EMC 1924 J Prevett Vol#: 195
EMC 1925 S Constantine Vol#: 195
EMC 1926 T Kienitz Vol#: 195
EMC 1927 S Argumedo Vol#: 195
EMC 1928 S Haskins Vol#: 195
EMC 1929 L Davis Vol#: 195
EMC 1930 M McCarty Vol#: 195
EMC 1931 D Reese Vol#: 195
EMC 1932 W Kobylarz Vol#: 195
EMC 1933 D Fazekas Vol#: 195
EMC 1934 E Porter Vol#: 195
EMC 1935 T Piatt Vol#: 195
EMC 1936 K Pomeroy Vol#: 195
EMC 1937 B Vol#: 195
EMC 1938 J Weisnewski Vol#: 195
EMC 1939 M Zagar Vol#: 195
EMC 1940 V Boe Vol#: 195
EMC 1941 V Mittal Vol#: 195
EMC 1942 P Goodkind Vol#: 195
EMC 1943 F Elmo Vol#: 195
EMC 1944 D Dollarhide Vol#: 195
EMC 1945 G Satary Vol#: 195
EMC 1946 KJorgensen Vol#: 195
EMC 1947 A Bowman Vol#: 195
EMC 1948 K. J. Vol#: 195
EMC 1949 R Quinn Vol#: 195
EMC 1950 S Robson Vol#: 195
00P-1265 Performance standard for electrode lead wires & patient cabl
CP 2 Biosense Webster Inc Vol#: 1
00P-1470 ANDA 75-880 for 6%and10% PremaSol-sulfite-free (Amino Acid)
CP 1 Baxter Healthcare Corporation Vol#: 1
Page updated October 6, 2003 jb