Cleared Traditional

K942339 - SKIN NEUVEAU SCAR TREATMENT
(FDA 510(k) Clearance)

K942339 · Puritas Health Care, Inc. · General & Plastic Surgery
Nov 1994
Decision
196d
Days
Class 1
Risk

K942339 is an FDA 510(k) clearance for the SKIN NEUVEAU 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 November 28, 1994, 196 days after receiving the submission on May 16, 1994.

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

Submission Details

510(k) Number K942339 FDA.gov
FDA Decision Cleared SESE
Date Received May 16, 1994
Decision Date November 28, 1994
Days to Decision 196 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Statement

Device Classification

Product Code MDA — Elastomer, Silicone, For Scar Management
Device Class Class I — General Controls
CFR Regulation 21 CFR 878.4025