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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 K913761
Device Name 3-D ACCUSCAN FACIAL IMPLANTS
Applicant
Implantech Associates, Inc.
1730 Pennsylvania Ave., NW
Washington,  DC  20006
Applicant Contact DVORAH A RICHMAN
Correspondent
Implantech Associates, Inc.
1730 Pennsylvania Ave., NW
Washington,  DC  20006
Correspondent Contact DVORAH A RICHMAN
Regulation Number878.3550
Classification Product Code
FWP  
Date Received08/21/1991
Decision Date 10/17/1991
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
Predetermined Change
Control Plan Authorized		 No
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