HYDROGEL SKIN DRESSING— 510(k) K962352

Name: FDA 510(k) clearance K962352
Creator: U.S. Food and Drug Administration
Published: 1996-08-02

Substantially Equivalent

North American Sterilization & Packaging Co.

FDA 510(k) clearance K962352 for HYDROGEL SKIN DRESSING, Substantially Equivalent on 1996-08-02. Applicant: North American Sterilization & Packaging Co.. Device class: 1.

Clearance details

Applicant: North American Sterilization & Packaging Co.
Product code: Code NAE
Device class: Class 1
Regulation: 21 CFR 878.4022
Advisory panel: General, Plastic Surgery
Date received: 1996-06-18
Decision date: 1996-08-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Sparta, NJ, 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.