FDA 510(k) Application Details - K052804

Device Classification Name	Devices, Breath Trapping, Alcohol   More FDA Info for this Device
510(K) Number	K052804
Device Name	Devices, Breath Trapping, Alcohol
Applicant	OMEGAPOINT SYSTEMS, LLC 310 TERRACE AVENUE, SUITE 201 CINCINNATI, OH 45220 US Other 510(k) Applications for this Company
Contact	BARBARA S FANT 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	10/04/2005
Decision Date	12/09/2005
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	TX - Clinical Toxicology
Review Advisory Committee	CH - Clinical Chemistry
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	Y
Expedited Review