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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 K022724
Device Name SURESTEP BLOOD GLUCOSE 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 Number862.1345
Classification Product Code
NBW  
Date Received08/16/2002
Decision Date 09/12/2002
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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