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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 K021419
Device Name AART MALAR IMPLANT
Applicant
Aesthetic and Reconstructive Technologies, Inc.
3545 Airway Dr.
Suite 108
Reno,  NV  89511
Applicant Contact CATHERINE RIPLE
Correspondent
Aesthetic and Reconstructive Technologies, Inc.
3545 Airway Dr.
Suite 108
Reno,  NV  89511
Correspondent Contact CATHERINE RIPLE
Regulation Number878.3550
Classification Product Code
LZK  
Date Received05/03/2002
Decision Date 07/02/2002
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
Recalls CDRH Recalls
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