Cleared Traditional

KERLIX ZINC SALINE DRESSING

K944468 · Kendall Healthcare Products Co. Div.Of Tyco Health · General & Plastic Surgery
Nov 1994
Decision
81d
Days
Class 1
Risk

About This 510(k) Submission

K944468 is an FDA 510(k) clearance for the KERLIX ZINC 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 November 29, 1994, 81 days after receiving the submission on September 9, 1994. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 880.5090.

Submission Details

510(k) Number K944468 FDA.gov
FDA Decision Cleared SN
Date Received September 09, 1994
Decision Date November 29, 1994
Days to Decision 81 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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