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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Glucose Oxidase, Glucose
510(k) Number K023194
Device Name SURESTEPPRO/SURESTEPFLEXX PROFESSIONAL BLOOD GLUCOSE MANAGEMENT SYSTEM
Applicant
Lifescan, Inc.
1000 Gibraltar Dr.
Milpitas,  CA  95035 -6312
Applicant Contact JOJN E HUGHES
Correspondent
Lifescan, Inc.
1000 Gibraltar Dr.
Milpitas,  CA  95035 -6312
Correspondent Contact JOJN E HUGHES
Regulation Number862.1345
Classification Product Code
CGA  
Subsequent Product Code
NBW  
Date Received09/25/2002
Decision Date 10/24/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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