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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 K971478
Device Name DURALASTIC ANATOMICAL CHIN IMPLANTS
Applicant
Allied Biomedical Corp.
3850 Ramada Dr., Suite C-2
Paso Robles,  CA  93446
Applicant Contact GERALD HANSON
Correspondent
Allied Biomedical Corp.
3850 Ramada Dr., Suite C-2
Paso Robles,  CA  93446
Correspondent Contact GERALD HANSON
Regulation Number878.3550
Classification Product Code
FWP  
Date Received04/23/1997
Decision Date 07/18/1997
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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