CONTAMINATION CONTAINMENT DRAPE— 510(k) K954212

Name: FDA 510(k) clearance K954212
Creator: U.S. Food and Drug Administration
Published: 1995-10-23

Substantially Equivalent

Engineering Controls For Medicine

FDA 510(k) clearance K954212 for CONTAMINATION CONTAINMENT DRAPE, Substantially Equivalent on 1995-10-23. Applicant: Engineering Controls For Medicine. Device class: 2.

Clearance details

Applicant: Engineering Controls For Medicine
Product code: Code KKX
Device class: Class 2
Regulation: 21 CFR 878.4370
Advisory panel: General, Plastic Surgery
Date received: 1995-09-07
Decision date: 1995-10-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Fort Worth, TX, US

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