DERMAPHYLYX CALCIUM ALGINATE WOUND DRESSING— 510(k) K991061

Name: FDA 510(k) clearance K991061
Creator: U.S. Food and Drug Administration
Published: 1999-06-28

Substantially Equivalent

Dermaphylyx, Inc.

FDA 510(k) clearance K991061 for DERMAPHYLYX CALCIUM ALGINATE WOUND DRESSING, Substantially Equivalent on 1999-06-28. Applicant: Dermaphylyx, Inc.. Device class: 1.

Clearance details

Applicant: Dermaphylyx, Inc.
Product code: Code NAE
Device class: Class 1
Regulation: 21 CFR 878.4022
Advisory panel: General, Plastic Surgery
Date received: 1999-03-30
Decision date: 1999-06-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Woburn, MA, 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.