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FDA 510(k) Application Details - K020679
Device Classification Name
Test, Time, Prothrombin
More FDA Info for this Device
510(K) Number
K020679
Device Name
Test, Time, Prothrombin
Applicant
HEMOSENSE, INC.
600 VALLEY WAY
MILPITAS, CA 95035 US
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Contact
Judith Blunt
Other 510(k) Applications for this Contact
Regulation Number
864.7750
More FDA Info for this Regulation Number
Classification Product Code
GJS
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/04/2002
Decision Date
05/06/2002
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
HE - Hematology
Review Advisory Committee
HE - Hematology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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