PROMAX SURGICAL DRAPES AND COVERS— 510(k) K980183

Name: FDA 510(k) clearance K980183
Creator: U.S. Food and Drug Administration
Published: 1998-02-26

Substantially Equivalent

Standard Textile Co., Inc.

FDA 510(k) clearance K980183 for PROMAX SURGICAL DRAPES AND COVERS, Substantially Equivalent on 1998-02-26. 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: 1998-01-20
Decision date: 1998-02-26
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.