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510(k) K053031

EXTENDSURE HBFASC CONTROL by Cantebury Scientific , Ltd. — Product Code JCM

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
December 7, 2005
Date Received
October 27, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Control, Hemoglobin, Abnormal
Device Class
Class II
Regulation Number
864.7415
Review Panel
HE
Submission Type

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