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More About Classification
Device
Product Code
Review Panel
Anesthesiology
General Hospital
Ear Nose & Throat
General & Plastic Surgery
Immunology
Ophthalmic
Radiology
Cardiovascular
Gastroenterology/Urology
Microbiology
Orthopedic
Clinical Chemistry
Neurology
Pathology
Toxicology
Dental
Hematology
Obstetrics/Gynecology
Physical Medicine
SubmissionType
510(k)
PMA
Contact ODE
510(k) Exempt
HDE
Enforcement Discretion
Regulation Number
Third Party Elligible
Yes
No
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Device Name (A-Z)
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Regulation Number (9-0)
Device Class
unclassified
I
II
III
III (513(f)(1))
not classified
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