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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 K032985
Device Name GLUCOLEADER ENHANCE SELF-MONITORING OF BLOOD GLUCOSE SYSTEM
Applicant
Hmd Biomedical, Inc.
3505 Sunset Ave.
Ocean,  NJ  07712
Applicant Contact JEFFREY FLEISHMAN
Correspondent
Hmd Biomedical, Inc.
3505 Sunset Ave.
Ocean,  NJ  07712
Correspondent Contact JEFFREY FLEISHMAN
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Code
CGA  
Date Received09/24/2003
Decision Date 10/21/2003
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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