BSM- BONE SUBSTITUTE MATERIAL— 510(k) K983009

Substantially Equivalent

Etex Corp.

FDA 510(k) clearance K983009 for BSM- BONE SUBSTITUTE MATERIAL, Substantially Equivalent on 1998-11-25. Applicant: Etex Corp.. Device class: 2.

Clearance details

Applicant: Etex Corp.
Product code: Code GXP
Device class: Class 2
Regulation: 21 CFR 882.5300
Advisory panel: Neurology
Date received: 1998-08-28
Decision date: 1998-11-25
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Cambridge, MA, 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.