Cleared Traditional

ALLEVYN DRESSING CLAIMS CHANGE

K904412 · Smith & Nephew United, Inc. · General & Plastic Surgery
Oct 1990
Decision
27d
Days
Class 1
Risk

About This 510(k) Submission

K904412 is an FDA 510(k) clearance for the ALLEVYN DRESSING CLAIMS CHANGE, a Beads, Hydrophilic, For Wound Exudate Absorption (Class I — General Controls, product code KOZ), submitted by Smith & Nephew United, Inc. (Largo, US). The FDA issued a Cleared decision on October 23, 1990, 27 days after receiving the submission on September 26, 1990. This device falls under the General & Plastic Surgery review panel. Regulated under 21 CFR 878.4018.

Submission Details

510(k) Number K904412 FDA.gov
FDA Decision Cleared SN
Date Received September 26, 1990
Decision Date October 23, 1990
Days to Decision 27 days
Submission Type Traditional
Review Panel General & Plastic Surgery (SU)
Summary —

Device Classification

Product Code KOZ — Beads, Hydrophilic, For Wound Exudate Absorption
Device Class Class I — General Controls
CFR Regulation 21 CFR 878.4018

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