BIODERM MEDICAL HYDROGEL ISLAND DRESSING— 510(k) K951166

Name: FDA 510(k) clearance K951166
Creator: U.S. Food and Drug Administration
Published: 1995-06-21

Substantially Equivalent

Bioderm, Inc.

FDA 510(k) clearance K951166 for BIODERM MEDICAL HYDROGEL ISLAND DRESSING, Substantially Equivalent on 1995-06-21. Applicant: Bioderm, Inc.. Device class: 1.

Clearance details

Applicant: Bioderm, Inc.
Product code: Code NAE
Device class: Class 1
Regulation: 21 CFR 878.4022
Advisory panel: General, Plastic Surgery
Date received: 1995-03-14
Decision date: 1995-06-21
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Wheaton, IL, 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.