Cleared Traditional

DERMASORB WOUND CONTACT LAYER DRESSING

K903645 · Convatec, A Division of E.R. Squibb & Sons · General & Plastic Surgery

Nov 1990

Decision

99d

Days

Class 1

Risk

About This 510(k) Submission

K903645 is an FDA 510(k) clearance for the DERMASORB WOUND CONTACT LAYER DRESSING, a Beads, Hydrophilic, For Wound Exudate Absorption (Class I — General Controls, product code KOZ), submitted by Convatec, A Division of E.R. Squibb & Sons (Princeton, US). The FDA issued a Cleared decision on November 21, 1990, 99 days after receiving the submission on August 14, 1990. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4018.

Submission Details

510(k) Number	K903645 FDA.gov
FDA Decision	Cleared SESE
Date Received	August 14, 1990
Decision Date	November 21, 1990
Days to Decision	99 days
Submission Type	Traditional
Review Panel	General & Plastic Surgery (SU)
Summary	—