Cleared Traditional

REDI-RELEASE ABSORBENT DRESSING

K904604 · Fountain Pharmaceuticals, Inc. · General & Plastic Surgery

Jan 1991

Decision

89d

Days

Class 1

Risk

About This 510(k) Submission

K904604 is an FDA 510(k) clearance for the REDI-RELEASE ABSORBENT DRESSING, a Beads, Hydrophilic, For Wound Exudate Absorption (Class I — General Controls, product code KOZ), submitted by Fountain Pharmaceuticals, Inc. (Largo, US). The FDA issued a Cleared decision on January 7, 1991, 89 days after receiving the submission on October 10, 1990. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4018.

Submission Details

510(k) Number	K904604 FDA.gov
FDA Decision	Cleared SESE
Date Received	October 10, 1990
Decision Date	January 07, 1991
Days to Decision	89 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	—