PELLEFIRM— 510(k) K132949

Substantially Equivalent

Ellman International, Inc.

FDA 510(k) clearance K132949 for PELLEFIRM, Substantially Equivalent on 2014-02-20. Applicant: Ellman International, Inc.. Device class: 2.

Clearance details

Applicant: Ellman International, Inc.
Product code: Code PBX
Device class: Class 2
Regulation: 21 CFR 878.4400
Advisory panel: General, Plastic Surgery
Date received: 2013-09-19
Decision date: 2014-02-20
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Hicksville, NY, 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.