EXTENDSURE HBFASC CONTROL— 510(k) K053031

Name: FDA 510(k) clearance K053031
Creator: U.S. Food and Drug Administration
Published: 2005-12-07

Substantially Equivalent

Cantebury Scientific , Ltd.

FDA 510(k) clearance K053031 for EXTENDSURE HBFASC CONTROL, Substantially Equivalent on 2005-12-07. Applicant: Cantebury Scientific , Ltd.. Device class: 2.

Clearance details

Applicant: Cantebury Scientific , Ltd.
Product code: Code JCM
Device class: Class 2
Regulation: 21 CFR 864.7415
Advisory panel: Hematology
Date received: 2005-10-27
Decision date: 2005-12-07
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Christchurch, Canterbury, NZ

Download summary PDF View on FDA.gov ↗

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