SILGEL TOPICAL GEL SHEET— 510(k) K960254

Name: FDA 510(k) clearance K960254
Creator: U.S. Food and Drug Administration
Published: 1996-04-02

Substantially Equivalent

Rofil Medical USA, Inc.

FDA 510(k) clearance K960254 for SILGEL TOPICAL GEL SHEET, Substantially Equivalent on 1996-04-02. Applicant: Rofil Medical USA, Inc.. Device class: 1.

Clearance details

Applicant: Rofil Medical USA, Inc.
Product code: Code MDA
Device class: Class 1
Regulation: 21 CFR 878.4025
Advisory panel: General, Plastic Surgery
Date received: 1996-01-17
Decision date: 1996-04-02
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Laguna Hills, CA, 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.