BUSSE SURGICAL DRAPE— 510(k) K082297

Name: FDA 510(k) clearance K082297
Creator: U.S. Food and Drug Administration
Published: 2008-12-09

Substantially Equivalent

Busse Hospital Disposables, Inc.

FDA 510(k) clearance K082297 for BUSSE SURGICAL DRAPE, Substantially Equivalent on 2008-12-09. Applicant: Busse Hospital Disposables, Inc.. Device class: 2.

Clearance details

Applicant: Busse Hospital Disposables, Inc.
Product code: Code KKX
Device class: Class 2
Regulation: 21 CFR 878.4370
Advisory panel: General, Plastic Surgery
Date received: 2008-08-12
Decision date: 2008-12-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hauppauge, NY, US

Download summary PDF View on FDA.gov ↗

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K073222 — MODIFICATION TO:SPECIALTY NEEDLES2008-04-09
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Data sourced from openFDA. This site is unofficial and independent of the FDA.