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510(k) K050821

COAGCARE ANTICOAGULATION MANAGEMENT SYSTEM by Zycare — Product Code KQG

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
August 16, 2005
Date Received
March 31, 2005
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Instrument, Coagulation
Device Class
Class II
Regulation Number
864.5400
Review Panel
HE
Submission Type

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