Cleared Traditional

ULCUFLEX HYDROCULLOID DRESSING

K920367 · Industrias Palex C/O Dma Med-Chem Corp. · General & Plastic Surgery

Mar 1992

Decision

58d

Days

Class 1

Risk

About This 510(k) Submission

K920367 is an FDA 510(k) clearance for the ULCUFLEX HYDROCULLOID DRESSING, a Bandage, Liquid (Class I — General Controls, product code KMF), submitted by Industrias Palex C/O Dma Med-Chem Corp. (Postal: Apartado 1940, ES). The FDA issued a Cleared decision on March 26, 1992, 58 days after receiving the submission on January 28, 1992. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 880.5090.

Submission Details

510(k) Number	K920367 FDA.gov
FDA Decision	Cleared SESE
Date Received	January 28, 1992
Decision Date	March 26, 1992
Days to Decision	58 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	Statement