BUSSE SURGICAL DRAPE— 510(k) K083424

Name: FDA 510(k) clearance K083424
Creator: U.S. Food and Drug Administration
Published: 2009-02-26

Substantially Equivalent

Busse Hosipital Disposables

FDA 510(k) clearance K083424 for BUSSE SURGICAL DRAPE, Substantially Equivalent on 2009-02-26. Applicant: Busse Hosipital Disposables. Device class: 2.

Clearance details

Applicant: Busse Hosipital Disposables
Product code: Code KKX
Device class: Class 2
Regulation: 21 CFR 878.4370
Advisory panel: General, Plastic Surgery
Date received: 2008-11-19
Decision date: 2009-02-26
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hauppauge, NY, US

Download summary PDF View on FDA.gov ↗

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