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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 K072727
Device Name INRATIO 2 PT MONITORING SYSTEM
Applicant
HEMOSENSE, INC.
651 RIVER OAKS PARKWAY
SAN JOSE,  CA  95134
Applicant Contact DOUG RUNDLE
Correspondent
HEMOSENSE, INC.
651 RIVER OAKS PARKWAY
SAN JOSE,  CA  95134
Correspondent Contact DOUG RUNDLE
Regulation Number864.7750
Classification Product Code
GJS  
Date Received09/26/2007
Decision Date 10/26/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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