SURGICAL CONCEPT DESIGNS POSITIONOR SURGICAL DRAPE— 510(k) K081476

Name: FDA 510(k) clearance K081476
Creator: U.S. Food and Drug Administration
Published: 2008-08-08

Substantially Equivalent

Surgical Concept Designs

FDA 510(k) clearance K081476 for SURGICAL CONCEPT DESIGNS POSITIONOR SURGICAL DRAPE, Substantially Equivalent on 2008-08-08. Applicant: Surgical Concept Designs. Device class: 2.

Clearance details

Applicant: Surgical Concept Designs
Product code: Code KKX
Device class: Class 2
Regulation: 21 CFR 878.4370
Advisory panel: General, Plastic Surgery
Date received: 2008-05-27
Decision date: 2008-08-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hackensack, NJ, US

Download summary PDF View on FDA.gov ↗

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