Cleared Traditional

AART SILICONE SHEETING

K022223 · Aesthetic and Reconstructive Technologies, Inc. · General & Plastic Surgery

Aug 2002

Decision

30d

Days

Class 2

Risk

About This 510(k) Submission

K022223 is an FDA 510(k) clearance for the AART SILICONE SHEETING, a Elastomer, Silicone Block (Class II — Special Controls, product code MIB), submitted by Aesthetic and Reconstructive Technologies, Inc. (Paso Robles, US). The FDA issued a Cleared decision on August 8, 2002, 30 days after receiving the submission on July 9, 2002. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 874.3620.

Submission Details

510(k) Number	K022223 FDA.gov
FDA Decision	Cleared SESE
Date Received	July 09, 2002
Decision Date	August 08, 2002
Days to Decision	30 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF