Cleared Traditional

CURASALT HYPERTONIC SALINE DRESSING

K942459 · Kendall Healthcare Products Co. Div.Of Tyco Health · General & Plastic Surgery
Jun 1994
Decision
34d
Days
Class 1
Risk

About This 510(k) Submission

K942459 is an FDA 510(k) clearance for the CURASALT HYPERTONIC SALINE 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 June 27, 1994, 34 days after receiving the submission on May 24, 1994. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 880.5090.

Submission Details

510(k) Number K942459 FDA.gov
FDA Decision Cleared SESE
Date Received May 24, 1994
Decision Date June 27, 1994
Days to Decision 34 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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