UHMWPE SURGICAL MESH— 510(k) K894478

Substantially Equivalent

Biomet, Inc.

FDA 510(k) clearance K894478 for UHMWPE SURGICAL MESH, Substantially Equivalent on 1990-03-08. Applicant: Biomet, Inc.. Device class: 2.

Clearance details

Applicant: Biomet, Inc.
Product code: Code KKY
Device class: Class 2
Regulation: 21 CFR 878.3500
Advisory panel: General, Plastic Surgery
Date received: 1989-07-18
Decision date: 1990-03-08
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Warsaw, IN, 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.