Cleared Traditional

CURADERM ALGINATE HYDROCOLLOID

K943636 · Kendall Healthcare Products Co. Div.Of Tyco Health · General & Plastic Surgery
Oct 1994
Decision
68d
Days
Class 1
Risk

About This 510(k) Submission

K943636 is an FDA 510(k) clearance for the CURADERM ALGINATE HYDROCOLLOID, 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 October 3, 1994, 68 days after receiving the submission on July 27, 1994. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 880.5090.

Submission Details

510(k) Number K943636 FDA.gov
FDA Decision Cleared SN
Date Received July 27, 1994
Decision Date October 03, 1994
Days to Decision 68 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary —

Device Classification

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

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