Cleared Traditional

AART NASAL IMPLANT

K021418 · Aesthetic and Reconstructive Technologies, Inc. · General & Plastic Surgery

Jul 2002

Decision

60d

Days

Class 2

Risk

About This 510(k) Submission

K021418 is an FDA 510(k) clearance for the AART NASAL IMPLANT, a Prosthesis, Nose, Internal (Class II — Special Controls, product code FZE), 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 878.3680.

Submission Details

510(k) Number	K021418 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