BSM BONE SUBSTITUTE MATERIAL KIT— 510(k) K962548

Substantially Equivalent

Etex Corp.

FDA 510(k) clearance K962548 for BSM BONE SUBSTITUTE MATERIAL KIT, Substantially Equivalent on 1997-08-05. Applicant: Etex Corp.. Device class: 2.

Clearance details

Applicant: Etex Corp.
Product code: Code LYC
Device class: Class 2
Regulation: 21 CFR 872.3930
Advisory panel: Dental
Date received: 1996-06-28
Decision date: 1997-08-05
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.