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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dye-Indicator, Ph (Urinary, Non-Quantitative)
510(k) Number K091287
Device Name VS-SENSE TEST
Applicant
Common Sense , Ltd.
777 6th St. NW
Suite 1100
Washington,  DC  20001
Applicant Contact NATASHA LESKOVSEK
Correspondent
Common Sense , Ltd.
777 6th St. NW
Suite 1100
Washington,  DC  20001
Correspondent Contact NATASHA LESKOVSEK
Regulation Number862.1550
Classification Product Code
CEN  
Date Received05/01/2009
Decision Date 08/31/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Clinical Chemistry
510k Review Panel Clinical Chemistry
Summary Summary
FDA Review Decision Summary
Type Traditional
Clinical Trials NCT00803127
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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