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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
Applicant Contact JOHN E HUGHES
Correspondent
Lifescan, Inc.
1000 Gibraltar Dr.
Milpitas,  CA  95035
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
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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