BIO-SCAFFOLD BIOSCAFF ALVELAC RESOBABLE SCAFFOLD— 510(k) K080308

Name: FDA 510(k) clearance K080308
Creator: U.S. Food and Drug Administration
Published: 2008-04-14

Substantially Equivalent

Bioscaffold International Pte, Ltd.

FDA 510(k) clearance K080308 for BIO-SCAFFOLD BIOSCAFF ALVELAC RESOBABLE SCAFFOLD, Substantially Equivalent on 2008-04-14. Applicant: Bioscaffold International Pte, Ltd.. Device class: 2.

Clearance details

Applicant: Bioscaffold International Pte, Ltd.
Product code: Code LYC
Device class: Class 2
Regulation: 21 CFR 872.3930
Advisory panel: Dental
Date received: 2008-02-05
Decision date: 2008-04-14
Decision: Substantially Equivalent
Clearance type: Abbreviated
Location: Rome, IT

Download summary PDF View on FDA.gov ↗

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