Cleared Traditional

AART CHIN IMPLANT

K021417 · Aesthetic and Reconstructive Technologies, Inc. · General & Plastic Surgery
Jul 2002
Decision
60d
Days
Class 2
Risk

About This 510(k) Submission

K021417 is an FDA 510(k) clearance for the AART CHIN IMPLANT, a Prosthesis, Chin, Internal (Class II — Special Controls, product code FWP), submitted by Aesthetic and Reconstructive Technologies, Inc. (Reno, US). The FDA issued a Cleared decision on July 2, 2002, 60 days after receiving the submission on May 3, 2002. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.3550.

Submission Details

510(k) Number K021417 FDA.gov
FDA Decision Cleared SESE
Date Received May 03, 2002
Decision Date July 02, 2002
Days to Decision 60 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code FWP — Prosthesis, Chin, Internal
Device Class Class II — Special Controls
CFR Regulation 21 CFR 878.3550

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