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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name test, time, prothrombin
510(k) Number K093243
Device Name COAGUSENSE SELF-TEST PROTHROMBIN TIME/INR MONITORING SYSTEM
Applicant
COAGUSENSE, INC
42840 CHRISTY ST SUITE 110
FREMONT,  CA  94538
Applicant Contact DOUGLAS PATERSON
Correspondent
COAGUSENSE, INC
42840 CHRISTY ST SUITE 110
FREMONT,  CA  94538
Correspondent Contact DOUGLAS PATERSON
Regulation Number864.7750
Classification Product Code
GJS  
Date Received10/15/2009
Decision Date 04/07/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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