AWC BUTTERFLY WOUND CLOSURES— 510(k) K894802

Name: FDA 510(k) clearance K894802
Creator: U.S. Food and Drug Administration
Published: 1990-01-31

Substantially Equivalent

American White Cross, Inc.

FDA 510(k) clearance K894802 for AWC BUTTERFLY WOUND CLOSURES, Substantially Equivalent on 1990-01-31. Applicant: American White Cross, Inc.. Device class: 1.

Clearance details

Applicant: American White Cross, Inc.
Product code: Code FPX
Device class: Class 1
Regulation: 21 CFR 880.5240
Advisory panel: General Hospital
Date received: 1989-07-28
Decision date: 1990-01-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: New Rochelle, NY, 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.