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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 K091296
Device Name POLYTEL GMA, MODELS PWR-08-67, PWR-08-07, PWR-08-09
Applicant
Polymap Wireless
310 S. Williams Blvd., Suite 346
Tucson,  AZ  85711
Applicant Contact PIERRE LANDAU
Correspondent
Polymap Wireless
310 S. Williams Blvd., Suite 346
Tucson,  AZ  85711
Correspondent Contact PIERRE LANDAU
Regulation Number862.1345
Classification Product Code
NBW  
Date Received05/04/2009
Decision Date 07/17/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Abbreviated
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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