SKIN BARRIER FILM— 510(k) K092712

Substantially Equivalent

Lodestar Products, Inc.

FDA 510(k) clearance K092712 for SKIN BARRIER FILM, Substantially Equivalent on 2010-02-23. Applicant: Lodestar Products, Inc.. Device class: 1.

Clearance details

Applicant: Lodestar Products, Inc.
Product code: Code KMF
Device class: Class 1
Regulation: 21 CFR 880.5090
Advisory panel: General Hospital
Date received: 2009-09-03
Decision date: 2010-02-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Plano, TX, 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.