TENCEL TOPICAL WOUND DRESSING/SURGICAL SPONGE— 510(k) K921227

Name: FDA 510(k) clearance K921227
Creator: U.S. Food and Drug Administration
Published: 1992-05-29

Substantially Equivalent

Courtaulds Fibers, Inc.

FDA 510(k) clearance K921227 for TENCEL TOPICAL WOUND DRESSING/SURGICAL SPONGE, Substantially Equivalent on 1992-05-29. Applicant: Courtaulds Fibers, Inc.. Device class: 1.

Clearance details

Applicant: Courtaulds Fibers, Inc.
Product code: Code NAB
Device class: Class 1
Regulation: 21 CFR 878.4014
Advisory panel: General, Plastic Surgery
Date received: 1992-03-13
Decision date: 1992-05-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Axis, AL, US

Download summary PDF View on FDA.gov ↗

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