Cleared Traditional

SKIN SAVER SYSTEMS

K952738 · Skin Saver Systems, Inc. · General Hospital

Sep 1995

Decision

107d

Days

Class 1

Risk

About This 510(k) Submission

K952738 is an FDA 510(k) clearance for the SKIN SAVER SYSTEMS, a Bandage, Elastic (Class I — General Controls, product code FQM), submitted by Skin Saver Systems, Inc. (Aurora, US). The FDA issued a Cleared decision on September 29, 1995, 107 days after receiving the submission on June 14, 1995. This device falls under the General Hospital review panel. Regulated under 21 CFR 880.5075.

Submission Details

510(k) Number	K952738 FDA.gov
FDA Decision	Cleared SESE
Date Received	June 14, 1995
Decision Date	September 29, 1995
Days to Decision	107 days
Submission Type	Traditional
Review Panel	General Hospital (HO)
Summary	Statement