SILVERFIL— 510(k) K053114

Name: FDA 510(k) clearance K053114
Creator: U.S. Food and Drug Administration
Published: 2005-11-15

Substantially Equivalent

Dunia Perwira Manufacturing Sdn. Bhd.

FDA 510(k) clearance K053114 for SILVERFIL, Substantially Equivalent on 2005-11-15. Applicant: Dunia Perwira Manufacturing Sdn. Bhd.. Device class: 2.

Clearance details

Applicant: Dunia Perwira Manufacturing Sdn. Bhd.
Product code: Code EJJ
Device class: Class 2
Regulation: 21 CFR 872.3070
Advisory panel: Dental
Date received: 2005-11-07
Decision date: 2005-11-15
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Upm Serdang, Selangor, MY

Download summary PDF View on FDA.gov ↗

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