Cleared Traditional

K012419 - CONFORM SHEETING, MODEL IGEL
(FDA 510(k) Clearance)

K012419 · Implantech Associates, Inc. · General & Plastic Surgery device

Oct 2001

Decision

86d

Days

Class 1

Risk

K012419 is an FDA 510(k) clearance for the CONFORM SHEETING, MODEL IGEL. This device is classified as a Elastomer, Silicone, For Scar Management (Class I - General Controls, product code MDA).

Submitted by Implantech Associates, Inc. (Ventura, US). The FDA issued a Cleared decision on October 24, 2001, 86 days after receiving the submission on July 30, 2001.

This device falls under the General & Plastic Surgery FDA review panel. Regulated under 21 CFR 878.4025.

Submission Details

510(k) Number	K012419 FDA.gov
FDA Decision	Cleared Substantially Equivalent - Traditional 510(k) (SESE)
Date Received	July 30, 2001
Decision Date	October 24, 2001
Days to Decision	86 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Statement