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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 K994006
Device Name AVOCET ACUSURE (FOR PATIENT SELF-TESTING) AND AVOCET ACUSURE PRO (FOR PROFESSIONAL USE)
Applicant
Avocet Medical, Inc.
100 Great Oaks Blvd.
San Jose,  CA  95119
Applicant Contact JILL FALCONE
Correspondent
Avocet Medical, Inc.
100 Great Oaks Blvd.
San Jose,  CA  95119
Correspondent Contact JILL FALCONE
Regulation Number864.7750
Classification Product Code
GJS  
Date Received11/24/1999
Decision Date 02/03/2000
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
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