FDA 510(k) Application Details - K072953

Device Classification Name	Devices, Breath Trapping, Alcohol   More FDA Info for this Device
510(K) Number	K072953
Device Name	Devices, Breath Trapping, Alcohol
Applicant	REDLINE PRODUCTS (PTY) LTD. 10 CROMPTON ROAD STRAND INDUSTRIA, WESTERN CAPE 7140 ZA Other 510(k) Applications for this Company
Contact	HUGH A BUTLER 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	10/18/2007
Decision Date	01/07/2008
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	TX - Clinical Toxicology
Review Advisory Committee	TX - Clinical Toxicology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review