Cleared Traditional

K940404 - ALGINATE FIBER TOPICAL WOUND DRESSING
(FDA 510(k) Clearance)

K940404 · Adri · General & Plastic Surgery

May 1994

Decision

97d

Days

Class 1

Risk

K940404 is an FDA 510(k) clearance for the ALGINATE FIBER TOPICAL WOUND DRESSING, a Bandage, Liquid (Class I — General Controls, product code KMF), submitted by Adri (Park Forest, US). The FDA issued a Cleared decision on May 4, 1994, 97 days after receiving the submission on January 27, 1994. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 880.5090.

Submission Details

510(k) Number	K940404 FDA.gov
FDA Decision	Cleared SN
Date Received	January 27, 1994
Decision Date	May 04, 1994
Days to Decision	97 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	—