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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 K902827
Device Name ANATOMICAL MANDIBULAR IMPLANT STYLE II
Applicant
IMPLANTECH ASSOCIATES, INC.
1730 PENNSYLVANIA AVENUE, NW
WASHINGTON,  DC  20006
Applicant Contact EDWARD BASILE
Correspondent
IMPLANTECH ASSOCIATES, INC.
1730 PENNSYLVANIA AVENUE, NW
WASHINGTON,  DC  20006
Correspondent Contact EDWARD BASILE
Regulation Number878.3550
Classification Product Code
FWP  
Date Received06/28/1990
Decision Date 08/01/1990
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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