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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name instrument, coagulation
510(k) Number K050821
Device Name COAGCARE ANTICOAGULATION MANAGEMENT SYSTEM
Applicant
ZYCARE
3804 SWEETEN CREEK RD.
CHAPEL HILL,  NC  27514
Applicant Contact STEVE D HOLDAWAY
Correspondent
ZYCARE
3804 SWEETEN CREEK RD.
CHAPEL HILL,  NC  27514
Correspondent Contact STEVE D HOLDAWAY
Regulation Number864.5400
Classification Product Code
KQG  
Date Received03/31/2005
Decision Date 08/16/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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