FDA 510(k) Application Details - K093143

Device Classification Name	Devices, Breath Trapping, Alcohol   More FDA Info for this Device
510(K) Number	K093143
Device Name	Devices, Breath Trapping, Alcohol
Applicant	ACON LABORATORIES, INC. 10125 MESA RIM RD. SAN DIEGO, CA 92121 US Other 510(k) Applications for this Company
Contact	RICHARD LENART 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	10/05/2009
Decision Date	01/28/2010
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