MEDICAL Z, S.A. MEDIGEL Z SCAR MANAGEMENT GEL— 510(k) K971916

Name: FDA 510(k) clearance K971916
Creator: U.S. Food and Drug Administration
Published: 1997-07-29

Substantially Equivalent

Medical Z, S.A.

FDA 510(k) clearance K971916 for MEDICAL Z, S.A. MEDIGEL Z SCAR MANAGEMENT GEL, Substantially Equivalent on 1997-07-29. Applicant: Medical Z, S.A.. Device class: 1.

Clearance details

Applicant: Medical Z, S.A.
Product code: Code MDA
Device class: Class 1
Regulation: 21 CFR 878.4025
Advisory panel: General, Plastic Surgery
Date received: 1997-05-23
Decision date: 1997-07-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Washington, DC, 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.