COMBOSAFE (EUROPE) AND PROMAX (US) SURGICAL GOWNS— 510(k) K041540

Substantially Equivalent

Standard Textile Co., Inc.

FDA 510(k) clearance K041540 for COMBOSAFE (EUROPE) AND PROMAX (US) SURGICAL GOWNS, Substantially Equivalent on 2005-05-05. Applicant: Standard Textile Co., Inc..

Clearance details

Applicant: Standard Textile Co., Inc.
Product code: Code FYA
Advisory panel: General, Plastic Surgery
Date received: 2004-06-08
Decision date: 2005-05-05
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cincinnati, OH, US

Download summary PDF View on FDA.gov ↗

Data sourced from openFDA. This site is unofficial and independent of the FDA.