FOUNDATION— 510(k) K111087

Name: FDA 510(k) clearance K111087
Creator: U.S. Food and Drug Administration
Published: 2011-11-29

Substantially Equivalent

Olympus Terumo Biomaterials Corporation

FDA 510(k) clearance K111087 for FOUNDATION, Substantially Equivalent on 2011-11-29. Applicant: Olympus Terumo Biomaterials Corporation. Device class: 2.

Clearance details

Applicant: Olympus Terumo Biomaterials Corporation
Product code: Code LYC
Device class: Class 2
Regulation: 21 CFR 872.3930
Advisory panel: Dental
Date received: 2011-04-19
Decision date: 2011-11-29
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Chevy Chase, MD, US

Download summary PDF View on FDA.gov ↗

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