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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 K931500
Device Name THE PERMARIDGE MATRIX CHIN
Applicant
Applied Biomaterial Technologies
3500 NW Anderson Hill Rd.
Suite #101
Silverdale,  WA  98383
Applicant Contact GERALD HANSON
Correspondent
Applied Biomaterial Technologies
3500 NW Anderson Hill Rd.
Suite #101
Silverdale,  WA  98383
Correspondent Contact GERALD HANSON
Regulation Number878.3550
Classification Product Code
FWP  
Date Received03/25/1993
Decision Date 11/17/1994
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
Predetermined Change
Control Plan Authorized		 No
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