MEDPOR CUSTOMIZED SURGICAL IMPLANT— 510(k) K083621

Name: FDA 510(k) clearance K083621
Creator: U.S. Food and Drug Administration
Published: 2009-02-03

Substantially Equivalent

Porex Surgical, Inc.

FDA 510(k) clearance K083621 for MEDPOR CUSTOMIZED SURGICAL IMPLANT, Substantially Equivalent on 2009-02-03. Applicant: Porex Surgical, Inc.. Device class: 2.

Clearance details

Applicant: Porex Surgical, Inc.
Product code: Code JOF
Device class: Class 2
Regulation: 21 CFR 874.3620
Advisory panel: Ear, Nose, Throat
Date received: 2008-12-08
Decision date: 2009-02-03
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Newnan, GA, 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.