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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Accessories, Catheter
510(k) Number K022306
Device Name AART SILICONE TUBING
Applicant
Aesthetic and Reconstructive Technologies, Inc.
5871 Lone Pine Pl.
Paso Robles,  CA  93446
Applicant Contact CATHERINE RIPLE
Correspondent
Aesthetic and Reconstructive Technologies, Inc.
5871 Lone Pine Pl.
Paso Robles,  CA  93446
Correspondent Contact CATHERINE RIPLE
Regulation Number878.4200
Classification Product Code
KGZ  
Date Received07/16/2002
Decision Date 10/10/2002
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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