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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Devices, Breath Trapping, Alcohol
510(k) Number K052448
Device Name POCKET BREATHALYZER. CONNECTABLES
Applicant
Connectables, LLC
2340 Ernie Krueger Cir.
Waukegan,  IL  60087
Applicant Contact PHILLIP H CORSE
Correspondent
Connectables, LLC
2340 Ernie Krueger Cir.
Waukegan,  IL  60087
Correspondent Contact PHILLIP H CORSE
Regulation Number862.3050
Classification Product Code
DJZ  
Date Received09/07/2005
Decision Date 02/23/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Toxicology
510k Review Panel Toxicology
Summary Summary
FDA Review Decision Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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