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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Implant, Malar
510(k) Number K873434
Device Name CREAT BRAND MALAR IMPLANT
Applicant
Aesthetech Corp.
Post Office Box 278
634 Airport Rd.
Paso Robles,  CA  93447
Applicant Contact THOMAS D SALISBURY
Correspondent
Aesthetech Corp.
Post Office Box 278
634 Airport Rd.
Paso Robles,  CA  93447
Correspondent Contact THOMAS D SALISBURY
Regulation Number878.3550
Classification Product Code
LZK  
Date Received08/26/1987
Decision Date 09/11/1987
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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