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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 K062545
Device Name RMI LCD ALCOHOL DETECTOR
Applicant
Resource Management International, LLC
2330 Ernie Krueger Cir.
Waukegan,  IL  60087
Applicant Contact DANIEL KAMM
Correspondent
Resource Management International, LLC
2330 Ernie Krueger Cir.
Waukegan,  IL  60087
Correspondent Contact DANIEL KAMM
Regulation Number862.3050
Classification Product Code
DJZ  
Date Received08/30/2006
Decision Date 04/09/2007
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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