ACTICOAT SILVER COATED DRESSING— 510(k) K955453

Name: FDA 510(k) clearance K955453
Creator: U.S. Food and Drug Administration
Published: 1996-05-31

Substantially Equivalent for Some Indications

Westaim Technologies, Inc.

FDA 510(k) clearance K955453 for ACTICOAT SILVER COATED DRESSING, Substantially Equivalent for Some Indications on 1996-05-31. Applicant: Westaim Technologies, Inc.. Device class: 1.

Clearance details

Applicant: Westaim Technologies, Inc.
Product code: Code KMF
Device class: Class 1
Regulation: 21 CFR 880.5090
Advisory panel: General Hospital
Date received: 1995-11-29
Decision date: 1996-05-31
Decision: Substantially Equivalent for Some Indications
Clearance type: Traditional
Location: Washington, DC, US

Download summary PDF View on FDA.gov ↗

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