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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name prosthesis, chin, internal
510(k) Number K914297
Device Name K.D. CHIN IMPLANT
Applicant
IMPLANTECH ASSOCIATES, INC.
1730 PENNSYLVANIA AVENUE, NW
WASHINGTON,  DC  20006
Applicant Contact DVORAH A RICHMAN
Correspondent
IMPLANTECH ASSOCIATES, INC.
1730 PENNSYLVANIA AVENUE, NW
WASHINGTON,  DC  20006
Correspondent Contact DVORAH A RICHMAN
Regulation Number878.3550
Classification Product Code
FWP  
Date Received09/25/1991
Decision Date 12/19/1991
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
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