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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Implant, Malar
510(k) Number K973502
Device Name IMPLANTECH CONFORM BINDER SUBMALAR IMPLANT
Applicant
Implantech Associates, Inc.
1730 Pennsylvania Ave., NW
Washington,  DC  20006
Applicant Contact EDWARD M BASILE
Correspondent
Implantech Associates, Inc.
1730 Pennsylvania Ave., NW
Washington,  DC  20006
Correspondent Contact EDWARD M BASILE
Regulation Number878.3550
Classification Product Code
LZK  
Date Received09/16/1997
Decision Date 11/07/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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