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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
Recalls CDRH Recalls
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