Cleared Traditional

AART SILICONE CARVING BLOCK

K021820 · Aesthetic and Reconstructive Technologies, Inc. · General & Plastic Surgery

Jul 2002

Decision

42d

Days

Class 2

Risk

About This 510(k) Submission

K021820 is an FDA 510(k) clearance for the AART SILICONE CARVING BLOCK, 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 July 16, 2002, 42 days after receiving the submission on June 4, 2002. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 874.3620.

Submission Details

510(k) Number	K021820 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 04, 2002
Decision Date	July 16, 2002
Days to Decision	42 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Summary PDF