3I CALCIUM SODIUM PHOSPHATE BONE CEMENT— 510(k) K003493

Name: FDA 510(k) clearance K003493
Creator: U.S. Food and Drug Administration
Published: 2001-02-09

Substantially Equivalent

Biomet, Inc.

FDA 510(k) clearance K003493 for 3I CALCIUM SODIUM PHOSPHATE BONE CEMENT, Substantially Equivalent on 2001-02-09. Applicant: Biomet, Inc.. Device class: 2.

Clearance details

Applicant: Biomet, Inc.
Product code: Code LYC
Device class: Class 2
Regulation: 21 CFR 872.3930
Advisory panel: Dental
Date received: 2000-11-13
Decision date: 2001-02-09
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.