NEWGEL AND NEWGEL PLUS E— 510(k) K041704

Name: FDA 510(k) clearance K041704
Creator: U.S. Food and Drug Administration
Published: 2005-10-17

Substantially Equivalent

Newmedical Technology, Inc.

FDA 510(k) clearance K041704 for NEWGEL AND NEWGEL PLUS E, Substantially Equivalent on 2005-10-17. Applicant: Newmedical Technology, Inc.. Device class: 1.

Clearance details

Applicant: Newmedical Technology, Inc.
Product code: Code MDA
Device class: Class 1
Regulation: 21 CFR 878.4025
Advisory panel: General, Plastic Surgery
Date received: 2004-06-23
Decision date: 2005-10-17
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Northbrook, IL, US

Download summary PDF View on FDA.gov ↗

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