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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 K925610
Device Name FLEXIBLE HYDROXYLAPATITE/SILICONE SOFT CHIN IMPLAN
Applicant
MICROTEK MEDICAL, INC.
POST OFFICE BOX 2487
COLUMBUS,  MS  39704
Applicant Contact CLAUDE WRIGHT
Correspondent
MICROTEK MEDICAL, INC.
POST OFFICE BOX 2487
COLUMBUS,  MS  39704
Correspondent Contact CLAUDE WRIGHT
Regulation Number878.3550
Classification Product Code
FWP  
Date Received11/05/1992
Decision Date 11/18/1994
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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