Dockets: 2006P-0085: To Exempt the Class II device Cranial Orthoses from Premarket Notification Requirements under Section 510(m)(2)

2006P-0085: To Exempt the Class II device Cranial Orthoses from Premarket Notification Requirements under Section 510(m)(2)

Document #	Received Date	Filed Date	Submitter Code	Submitter		FR Date


ACK1	07/06/2006	07/06/2006	Federal Government	FDA-DDM to American Association of Neurological Surgeons					pdf
				Signature:	Jennie C. Butler

CP1	07/06/2006	07/06/2006	Private Industry	American Association of Neurological Surgeons					pdf References
				Signature:	Catherine Jeakle Hill

CR1	07/12/2006	07/12/2006	Federal Government	FDA/DDM to AANS/CNS					pdf
				Signature:	Gloria Ortega

C1	09/22/2006	09/22/2006	Private Industry	Powell Goldstein, LLP					pdf Attachments
				Signature:	Steven K. Stranne, M.D., J.D.

N1		10/23/2006	FDA	FDA		10/24/2006	62268-62269	11/24/2006	txt
				Signature:	KAHAN, S. LINDA

EC1	11/01/2006	10/31/2006	Health Professional	Mr. Mark Porth					htm

EC2	11/09/2006	11/06/2006	Device Industry	Monroe Prosthetics and Orthotics					htm
				Signature:	Jolly, David

EC3	11/13/2006	11/09/2006	Health Professional	Stellar Prosthetics and Orthotics					htm
				Signature:	Stellar, Sean

EC4	11/14/2006	11/13/2006	Health Professional	Dr. Timothy Mapstone					htm

C2	11/14/2006	11/08/2006	Drug Industry	MedicalCenter Brace& Limb, Inc.					pdf
				Signature:	James W. Sherrill, CO, LO

C3	11/14/2006	11/07/2006	Other Organization	Ballert Orthopedic					pdf
				Signature:	Gene Bernardoni and Carl Holzman

EC5	11/20/2006	11/17/2006	Health Professional	AANS/CNS Joint Section for Pediatric Neurosurgery					htm
				Signature:	Abbott, MD, Rick

C4	11/17/2006	11/14/2006	Health Care Association	Nobbe Orthopedics, Inc.					pdf
				Signature:	Sharadi Nobbe, RN

EC6	11/21/2006	11/20/2006	Health Professional	American Association of Neurological Surgeons/Cong					htm
				Signature:	Duhaime, Ann-Christine

EC7	11/21/2006	11/20/2006	Device Industry	Rainbow Babies and Childrens Hospital					htm
				Signature:	Cohen, Alan

C5	11/21/2006	11/16/2006	Health Care Association	Nouveau Prosthetics and Orthotics					pdf
				Signature:	Joseph Ghizzone, L.P.O.

C6	11/21/2006	11/16/2006	Health Care Association	Nouveau Prosthetics and Orthotics					pdf
				Signature:	Stuart Weiner, C.P.O.

C7	11/21/2006	11/17/2006	Health Care Association	Permanente Medical Group					pdf
				Signature:	Robert M. Menard, MD, FACS

C8	11/21/2006	11/20/2006	Health Care Association	Orhotics Choice (OC)					pdf
				Signature:	Dr. Joseph Boyle

C9	11/21/2006	11/15/2006	Health Care Association	American Orthotic & Prosthetic Association (AOPA)					Table of Contents
				Signature:	Kevin N. Bitting, BOC, CO and Sylvere

EC8	11/22/2006	11/21/2006	Health Professional	Children's Hospital, Boston					htm
				Signature:	Scott, R. Michael

EC9	11/22/2006	11/21/2006	Health Professional	Dr. Joseph Piatt, Jr., MD, FAAP					htm

EC10	11/22/2006	11/21/2006	Health Professional	Dr. Bruce Kaufman, MD					htm

EC11	11/22/2006	11/21/2006	Individual Consumer	Ms. Sheila Addis					htm

EC12	11/27/2006	11/22/2006	Health Professional	american society of pediatric neurosurgery					htm
				Signature:	boop, frederick

EC13	11/27/2006	11/22/2006	Health Care Association	AANS/CNS Forum on Drugs, Devices, and Biologics					pdf
				Signature:	Fessler, Richard

EC14	11/27/2006	11/23/2006	Health Professional	Section of Pediatric Neurosurgery, AANS/CNS					pdf
				Signature:	Wisoff, Jeffrey

EC15	11/27/2006	11/24/2006	Health Professional	Harvard Medical School/Children's Hospital, Boston					htm
				Signature:	Rogers, Gary

C10	11/24/2006	11/24/2006	Individual Consumer	Form Letters					sample

C11	11/27/2006	11/27/2006	Individual Consumer	Form Letters					sample

C12	11/27/2006	11/21/2006	Health Professional	R. Novak, MS CO

C13	11/22/2006	11/21/2006	Health Professional	D. Lima, CO, OTR/L

C14	11/24/2006	11/22/2006	Health Care Association	Children's Memorial Hospital					pdf Attachments
				Signature:	Frank A. Vicari, MD, FACS, FAAP

C15	11/27/2006	11/22/2006	Health Care Association	Ortho Pro Associates, Inc.					pdf
				Signature:	Aldo Alvarez MS, LPO and Terri Sparb

C16	11/27/2006	11/16/2006	Health Care Association	Cranial Therapies, Inc.					Table of Contents
				Signature:	Kevin N. Bitting, BOC, CO and Sylvere

C17	11/27/2006	11/21/2006	Health Care Association	Children Hospital Boston					pdf
				Signature:	R. Michael Scott, M.D.

C18	12/21/2006	12/13/2006	Health Care Association	Childrens Hospital Los Angeles					pdf
				Signature:	J. Gordon McComb, M.D.

N2		12/22/2006	FDA	FDA		12/26/2006	77400-77402		txt
				Signature:	SHUREN, JEFFREY

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Page last updated: February 22, 2007