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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Elastomer, Silicone Block
510(k) Number K021839
Device Name AART GLUTEAL IMPLANT
Applicant
AESTHETIC AND RECONSTRUCTIVE TECHNOLOGIES, INC.
5871 LONE PINE PLACE
PASO ROBLES,  CA  93446
Applicant Contact CATHERINE RIPLE
Correspondent
AESTHETIC AND RECONSTRUCTIVE TECHNOLOGIES, INC.
5871 LONE PINE PLACE
PASO ROBLES,  CA  93446
Correspondent Contact CATHERINE RIPLE
Regulation Number874.3620
Classification Product Code
MIB  
Date Received06/04/2002
Decision Date 07/16/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Ear Nose & Throat
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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