Cleared Traditional

K941197 - SILK*SKIN SCAR TREATMENT
(FDA 510(k) Clearance)

K941197 · Puritas Health Care, Inc. · General & Plastic Surgery

Aug 1994

Decision

150d

Days

Class 1

Risk

K941197 is an FDA 510(k) clearance for the SILK*SKIN SCAR TREATMENT. This device is classified as a Elastomer, Silicone, For Scar Management (Class I — General Controls, product code MDA).

Submitted by Puritas Health Care, Inc. (New Milford, US). The FDA issued a Cleared decision on August 11, 1994, 150 days after receiving the submission on March 14, 1994.

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

Submission Details

510(k) Number	K941197 FDA.gov
FDA Decision	Cleared SESE
Date Received	March 14, 1994
Decision Date	August 11, 1994
Days to Decision	150 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Statement