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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 K943644
Device Name IMPLANTECH TEMPORAL IMPLANT
Applicant
Implantech Associates, Inc.
7100 Hayvenhurst Ave.,
Suite 207
Van Nuys,  CA  91406
Applicant Contact EDWARD BASILE
Correspondent
Implantech Associates, Inc.
7100 Hayvenhurst Ave.,
Suite 207
Van Nuys,  CA  91406
Correspondent Contact EDWARD BASILE
Regulation Number878.3550
Classification Product Code
FWP  
Date Received07/27/1994
Decision Date 10/18/1994
Decision SE SUBJECT TO TRACKING REG (ST)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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