LYOFOAM EXTRA 'A' STERILE ADHESIVE WOUND DRESSING— 510(k) K961452

Name: FDA 510(k) clearance K961452
Creator: U.S. Food and Drug Administration
Published: 1996-05-31

Substantially Equivalent

Acme United Corp.

FDA 510(k) clearance K961452 for LYOFOAM EXTRA 'A' STERILE ADHESIVE WOUND DRESSING, Substantially Equivalent on 1996-05-31. Applicant: Acme United Corp.. Device class: 1.

Clearance details

Applicant: Acme United Corp.
Product code: Code KMF
Device class: Class 1
Regulation: 21 CFR 880.5090
Advisory panel: General Hospital
Date received: 1996-04-16
Decision date: 1996-05-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fairfield, CT, US

Download summary PDF View on FDA.gov ↗

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K871740 — LYOSHEET SURGICAL SHEET FOR BURNS1987-06-09
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Data sourced from openFDA. This site is unofficial and independent of the FDA.