DURASIL— 510(k) K952612

Substantially Equivalent

The S. F. Group, Inc.

FDA 510(k) clearance K952612 for DURASIL, Substantially Equivalent on 1995-11-22. Applicant: The S. F. Group, Inc.. Device class: 1.

Clearance details

Applicant: The S. F. Group, Inc.
Product code: Code MDA
Device class: Class 1
Regulation: 21 CFR 878.4025
Advisory panel: General, Plastic Surgery
Date received: 1995-06-07
Decision date: 1995-11-22
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Grand Junction, CO, 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.