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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
Predetermined Change
Control Plan Authorized		 No
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