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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 K014167
Device Name LIBERTY BLOOD GLUCOSE MONITORING SYSTEM
Applicant
Polymedica Pharmaceuticals, U.S.A., Inc.]
11 State St.
Woburn,  MA  01801
Applicant Contact PATRICIA COLLINS
Correspondent
Polymedica Pharmaceuticals, U.S.A., Inc.]
11 State St.
Woburn,  MA  01801
Correspondent Contact PATRICIA COLLINS
Regulation Number862.1345
Classification Product Code
NBW  
Subsequent Product Code
CGA  
Date Received12/19/2001
Decision Date 02/19/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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