Cleared Traditional

CURASORB ZN ALGINATE WOUND DRESSING

K950775 · Kendall Healthcare Products Co. Div.Of Tyco Health · General & Plastic Surgery
Apr 1995
Decision
41d
Days
Class 1
Risk

About This 510(k) Submission

K950775 is an FDA 510(k) clearance for the CURASORB ZN ALGINATE WOUND DRESSING, a Bandage, Liquid (Class I — General Controls, product code KMF), submitted by Kendall Healthcare Products Co. Div.Of Tyco Health (Mansfield, US). The FDA issued a Cleared decision on April 3, 1995, 41 days after receiving the submission on February 21, 1995. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 880.5090.

Submission Details

510(k) Number K950775 FDA.gov
FDA Decision Cleared SESE
Date Received February 21, 1995
Decision Date April 03, 1995
Days to Decision 41 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary Summary PDF

Device Classification

Product Code KMF — Bandage, Liquid
Device Class Class I — General Controls
CFR Regulation 21 CFR 880.5090

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