POROUS HDPE SURGICAL IMPLANTS, TO BE DISTRIBUTED UNDER VARIOUS TRADEMARKS INCLUDING EPOR, BIOPOR, MINOPOR & P-HDPE— 510(k) K022665

Name: FDA 510(k) clearance K022665
Creator: U.S. Food and Drug Administration
Published: 2002-10-09

Substantially Equivalent

Hohenstein Enterprises, Inc.

FDA 510(k) clearance K022665 for POROUS HDPE SURGICAL IMPLANTS, TO BE DISTRIBUTED UNDER VARIOUS TRADEMARKS INCLUDING EPOR, BIOPOR, MINOPOR & P-HDPE, Substantially Equivalent on 2002-10-09. Applicant: Hohenstein Enterprises, Inc.. Device class: 2.

Clearance details

Applicant: Hohenstein Enterprises, Inc.
Product code: Code KKY
Device class: Class 2
Regulation: 21 CFR 878.3500
Advisory panel: General, Plastic Surgery
Date received: 2002-08-09
Decision date: 2002-10-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Los Angeles, CA, US

Download summary PDF View on FDA.gov ↗

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