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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 K022922
Device Name HARMONY INR MONITORING SYSTEM
Applicant
LIFESCAN, INC.
1000 GIBRALTAR DR.
MILPITAS,  CA  95035 -6312
Applicant Contact JOHN E HUGHES
Correspondent
LIFESCAN, INC.
1000 GIBRALTAR DR.
MILPITAS,  CA  95035 -6312
Correspondent Contact JOHN E HUGHES
Regulation Number864.7750
Classification Product Code
GJS  
Date Received09/04/2002
Decision Date 09/30/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Hematology
510k Review Panel Hematology
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
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