FDA 510(k) Application Details - K062545

Device Classification Name	Devices, Breath Trapping, Alcohol   More FDA Info for this Device
510(K) Number	K062545
Device Name	Devices, Breath Trapping, Alcohol
Applicant	RESOURCE MANAGEMENT INTERNATIONAL, LLC 2330 ERNIE KRUEGER CIRCLE WAUKEGAN, IL 60087 US Other 510(k) Applications for this Company
Contact	DANIEL KAMM Other 510(k) Applications for this Contact
Regulation Number	862.3050   More FDA Info for this Regulation Number
Classification Product Code	DJZ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/30/2006
Decision Date	04/09/2007
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	TX - Clinical Toxicology
Review Advisory Committee	TX - Clinical Toxicology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review