FDA 510(k) Application Details - K091714

Device Classification Name	Devices, Breath Trapping, Alcohol   More FDA Info for this Device
510(K) Number	K091714
Device Name	Devices, Breath Trapping, Alcohol
Applicant	SKYFINE INC. LIMITED NO.45, MINSHENG RD., DANSHUI TOWN( INNOVATION& INCUBATION C TAIPEI COUNTY 251 TW Other 510(k) Applications for this Company
Contact	MICHAEL LEE 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	06/10/2009
Decision Date	11/18/2009
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