COBES SURGICAL DRAPE— 510(k) K112378

Name: FDA 510(k) clearance K112378
Creator: U.S. Food and Drug Administration
Published: 2012-05-08

Substantially Equivalent

Cobes Industries Co., Ltd.

FDA 510(k) clearance K112378 for COBES SURGICAL DRAPE, Substantially Equivalent on 2012-05-08. Applicant: Cobes Industries Co., Ltd.. Device class: 2.

Clearance details

Applicant: Cobes Industries Co., Ltd.
Product code: Code KKX
Device class: Class 2
Regulation: 21 CFR 878.4370
Advisory panel: General, Plastic Surgery
Date received: 2011-08-18
Decision date: 2012-05-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Dover, DE, 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.