GILTECH PLUS HYDROGEL SKIN DRESSING— 510(k) K992094

Name: FDA 510(k) clearance K992094
Creator: U.S. Food and Drug Administration
Published: 1999-09-17

Substantially Equivalent

Giltech Plus, Inc.

FDA 510(k) clearance K992094 for GILTECH PLUS HYDROGEL SKIN DRESSING, Substantially Equivalent on 1999-09-17. Applicant: Giltech Plus, Inc.. Device class: 1.

Clearance details

Applicant: Giltech Plus, Inc.
Product code: Code NAE
Device class: Class 1
Regulation: 21 CFR 878.4022
Advisory panel: General, Plastic Surgery
Date received: 1999-06-21
Decision date: 1999-09-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Milford, PA, 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.