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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 K812210
Device Name CREAT BRAND WAGNER CHIN IMPLANT
Applicant
AESTHETECH CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Correspondent
AESTHETECH CORP.
803 N. Front St. Suite 3
McHenry,  IL  60050
Regulation Number878.3550
Classification Product Code
FWP  
Date Received08/04/1981
Decision Date 09/11/1981
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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