LAC-MAC LIMITED INNERBLOC VARIOUS O.R. DRAPE BASED ON THE REPEL, PLUS AND GORE SURGICAL BARRIER FABRIC MATERIALS— 510(k) K031362

Name: FDA 510(k) clearance K031362
Creator: U.S. Food and Drug Administration
Published: 2003-05-30

Substantially Equivalent

Lac Mac, Ltd.

FDA 510(k) clearance K031362 for LAC-MAC LIMITED INNERBLOC VARIOUS O.R. DRAPE BASED ON THE REPEL, PLUS AND GORE SURGICAL BARRIER FABRIC MATERIALS, Substantially Equivalent on 2003-05-30. Applicant: Lac Mac, Ltd.. Device class: 2.

Clearance details

Applicant: Lac Mac, Ltd.
Product code: Code KKX
Device class: Class 2
Regulation: 21 CFR 878.4370
Advisory panel: General, Plastic Surgery
Date received: 2003-02-20
Decision date: 2003-05-30
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Austin, TX, US

Download summary PDF View on FDA.gov ↗

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