DIMISIL SCAR GEL— 510(k) K023678

Name: FDA 510(k) clearance K023678
Creator: U.S. Food and Drug Administration
Published: 2003-01-23

Substantially Equivalent

Aesthetic and Reconstructive Technologies, Inc.

FDA 510(k) clearance K023678 for DIMISIL SCAR GEL, Substantially Equivalent on 2003-01-23. Applicant: Aesthetic and Reconstructive Technologies, Inc.. Device class: 1.

Clearance details

Applicant: Aesthetic and Reconstructive Technologies, Inc.
Product code: Code MDA
Device class: Class 1
Regulation: 21 CFR 878.4025
Advisory panel: General, Plastic Surgery
Date received: 2002-11-01
Decision date: 2003-01-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Paso Robles, CA, US

Download summary PDF View on FDA.gov ↗

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