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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name System, Test, Blood Glucose, Over The Counter
510(k) Number K071393
Device Name JAZZ BLOOD GLUCOSE MONITORING SYSTEM
Applicant
AGAMATRIX
10 MAOR PARKWAY
SALEM,  NH  03079
Applicant Contact CONNIE HERTEL
Correspondent
AGAMATRIX
10 MAOR PARKWAY
SALEM,  NH  03079
Correspondent Contact CONNIE HERTEL
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Code
CGA  
Date Received05/21/2007
Decision Date 07/20/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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