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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
Predetermined Change
Control Plan Authorized		 No
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