SOOTHE & SMOOTH SCAR CARE - SILICONE SHEETING— 510(k) K991312

Name: FDA 510(k) clearance K991312
Creator: U.S. Food and Drug Administration
Published: 1999-08-20

Substantially Equivalent

Library Medical, Inc.

FDA 510(k) clearance K991312 for SOOTHE & SMOOTH SCAR CARE - SILICONE SHEETING, Substantially Equivalent on 1999-08-20. Applicant: Library Medical, Inc.. Device class: 1.

Clearance details

Applicant: Library Medical, Inc.
Product code: Code MDA
Device class: Class 1
Regulation: 21 CFR 878.4025
Advisory panel: General, Plastic Surgery
Date received: 1999-04-16
Decision date: 1999-08-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Pittsburgh, PA, 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.