Cleared Traditional

MULTICURE(R) S GEL PAD

K950085 · Multigestion (Deutschland) GmbH · Physical Medicine

Jul 1995

Decision

184d

Days

Class 1

Risk

About This 510(k) Submission

K950085 is an FDA 510(k) clearance for the MULTICURE(R) S GEL PAD, a Cushion, Flotation (Class I — General Controls, product code KIC), submitted by Multigestion (Deutschland) GmbH (Saint Victor De Gessieu, FR). The FDA issued a Cleared decision on July 13, 1995, 184 days after receiving the submission on January 10, 1995. This device falls under the Physical Medicine review panel. Regulated under 21 CFR 890.3175.

Submission Details

510(k) Number	K950085 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 10, 1995
Decision Date	July 13, 1995
Days to Decision	184 days
Submission Type	Traditional
Review Panel	Physical Medicine (PM)
Summary	Statement