Cleared Traditional

KENDALL CURITY NON-ADHERING DRESSING

K973619 · Kendall Healthcare Products Co. Div.Of Tyco Health · General & Plastic Surgery
Dec 1997
Decision
78d
Days
Class 1
Risk

About This 510(k) Submission

K973619 is an FDA 510(k) clearance for the KENDALL CURITY NON-ADHERING 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 December 10, 1997, 78 days after receiving the submission on September 23, 1997. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 880.5090.

Submission Details

510(k) Number K973619 FDA.gov
FDA Decision Cleared SN
Date Received September 23, 1997
Decision Date December 10, 1997
Days to Decision 78 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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