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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 K020679
Device Name INRATIO
Applicant
HEMOSENSE, INC.
600 VALLEY WAY
MILPITAS,  CA  95035
Applicant Contact Judith Blunt
Correspondent
HEMOSENSE, INC.
600 VALLEY WAY
MILPITAS,  CA  95035
Correspondent Contact Judith Blunt
Regulation Number864.7750
Classification Product Code
GJS  
Date Received03/04/2002
Decision Date 05/06/2002
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
Recalls CDRH Recalls
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