COMPEL SURGICALDRAPES— 510(k) K944863

Name: FDA 510(k) clearance K944863
Creator: U.S. Food and Drug Administration
Published: 1995-02-28

Substantially Equivalent

Standard Textile Co., Inc.

FDA 510(k) clearance K944863 for COMPEL SURGICALDRAPES, Substantially Equivalent on 1995-02-28. Applicant: Standard Textile Co., Inc.. Device class: 2.

Clearance details

Applicant: Standard Textile Co., Inc.
Product code: Code KKX
Device class: Class 2
Regulation: 21 CFR 878.4370
Advisory panel: General, Plastic Surgery
Date received: 1994-10-03
Decision date: 1995-02-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cincinnati, OH, 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.