LTN - LAPAROSCOPIC SURGICAL MESH— 510(k) K130817

Name: FDA 510(k) clearance K130817
Creator: U.S. Food and Drug Administration
Published: 2013-04-17

Substantially Equivalent

Lifecell Corp.

FDA 510(k) clearance K130817 for LTN - LAPAROSCOPIC SURGICAL MESH, Substantially Equivalent on 2013-04-17. Applicant: Lifecell Corp.. Device class: 2.

Clearance details

Applicant: Lifecell Corp.
Product code: Code OXK
Device class: Class 2
Regulation: 21 CFR 878.3300
Advisory panel: General, Plastic Surgery
Date received: 2013-03-25
Decision date: 2013-04-17
Decision: Substantially Equivalent
Clearance type: Special
Location: Branchburg, NJ, 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.