BONESOURCE HYDROXYAPATITE CEMENT (HAC)— 510(k) K964537

Name: FDA 510(k) clearance K964537
Creator: U.S. Food and Drug Administration
Published: 1997-01-24

Substantially Equivalent

Osteogenics, Inc.

FDA 510(k) clearance K964537 for BONESOURCE HYDROXYAPATITE CEMENT (HAC), Substantially Equivalent on 1997-01-24. Applicant: Osteogenics, Inc.. Device class: 2.

Clearance details

Applicant: Osteogenics, Inc.
Product code: Code GXP
Device class: Class 2
Regulation: 21 CFR 882.5300
Advisory panel: Neurology
Date received: 1996-11-12
Decision date: 1997-01-24
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Richardson, TX, 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.