FDA 510(k) Application Details - K082086

Device Classification Name	Devices, Breath Trapping, Alcohol   More FDA Info for this Device
510(K) Number	K082086
Device Name	Devices, Breath Trapping, Alcohol
Applicant	THE ASHLEY COLLECTION, INC. 600 WEST 57TH ST. NEW YORK, NY 10019 US Other 510(k) Applications for this Company
Contact	ROBERT GOLDY 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	07/23/2008
Decision Date	12/19/2008
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