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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 K083801
Device Name BACTRACK SELECT BREATHALYZER, MODELS S30, S50, S70
Applicant
Khn Solutions, LLC
P.O. Box 7007
Deer Field,  IL  60015
Applicant Contact DANIEL KAMM
Correspondent
Khn Solutions, LLC
P.O. Box 7007
Deer Field,  IL  60015
Correspondent Contact DANIEL KAMM
Regulation Number862.3050
Classification Product Code
DJZ  
Date Received12/22/2008
Decision Date 03/19/2009
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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