OSFERION D— 510(k) K081561

Name: FDA 510(k) clearance K081561
Creator: U.S. Food and Drug Administration
Published: 2008-07-28

Substantially Equivalent

Olympus Terumo Biomaterials Corporation

FDA 510(k) clearance K081561 for OSFERION D, Substantially Equivalent on 2008-07-28. 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: 2008-06-03
Decision date: 2008-07-28
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Center Valley, PA, US

Download summary PDF View on FDA.gov ↗

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