FDA 510(k) Application Details - K072136

Device Classification Name	Nebulizer (Direct Patient Interface)   More FDA Info for this Device
510(K) Number	K072136
Device Name	Nebulizer (Direct Patient Interface)
Applicant	WILFRED KROMKER GMBH S65 W35739 PIPER ROAD EAGLE, WI 53119 US Other 510(k) Applications for this Company
Contact	STEPHEN GORSKI Other 510(k) Applications for this Contact
Regulation Number	868.5630   More FDA Info for this Regulation Number
Classification Product Code	CAF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	08/02/2007
Decision Date	07/15/2008
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review