Cleared Traditional

K941960 - IMPLANTECH DORSAL COLUMELLA IMPLANT STYLE II
(FDA 510(k) Clearance)

K941960 · Implantech Associates, Inc. · General & Plastic Surgery

Aug 1994

Decision

117d

Days

Class 2

Risk

K941960 is an FDA 510(k) clearance for the IMPLANTECH DORSAL COLUMELLA IMPLANT STYLE II. This device is classified as a Prosthesis, Nose, Internal (Class II — Special Controls, product code FZE).

Submitted by Implantech Associates, Inc. (Washington, US). The FDA issued a Cleared decision on August 17, 1994, 117 days after receiving the submission on April 22, 1994.

This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.3680.

Submission Details

510(k) Number	K941960 FDA.gov
FDA Decision	Cleared SESE
Date Received	April 22, 1994
Decision Date	August 17, 1994
Days to Decision	117 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Statement