LYOFOAM EXTRA— 510(k) K952565

Name: FDA 510(k) clearance K952565
Creator: U.S. Food and Drug Administration
Published: 1995-11-14

Substantially Equivalent for Some Indications

Acme United Corp.

FDA 510(k) clearance K952565 for LYOFOAM EXTRA, Substantially Equivalent for Some Indications on 1995-11-14. 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: 1995-06-02
Decision date: 1995-11-14
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Fairfield, CT, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.