SCAR HEAL— 510(k) K971468

Substantially Equivalent

Specialty Systems, Inc.

FDA 510(k) clearance K971468 for SCAR HEAL, Substantially Equivalent on 1997-06-10. Applicant: Specialty Systems, Inc.. Device class: 1.

Clearance details

Applicant: Specialty Systems, Inc.
Product code: Code MDA
Device class: Class 1
Regulation: 21 CFR 878.4025
Advisory panel: General, Plastic Surgery
Date received: 1997-04-22
Decision date: 1997-06-10
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Western, FL, 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.