IMC SURGICAL DRAPE— 510(k) K100991

Name: FDA 510(k) clearance K100991
Creator: U.S. Food and Drug Administration
Published: 2010-10-05

Substantially Equivalent

International Medsurg Connection

FDA 510(k) clearance K100991 for IMC SURGICAL DRAPE, Substantially Equivalent on 2010-10-05. Applicant: International Medsurg Connection. Device class: 2.

Clearance details

Applicant: International Medsurg Connection
Product code: Code KKX
Device class: Class 2
Regulation: 21 CFR 878.4370
Advisory panel: General, Plastic Surgery
Date received: 2010-04-09
Decision date: 2010-10-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Schaumburg, IL, 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.