FDA 510(k) Application Details - K053605

Device Classification Name	Nebulizer (Direct Patient Interface)   More FDA Info for this Device
510(K) Number	K053605
Device Name	Nebulizer (Direct Patient Interface)
Applicant	TRUDELL MEDICAL INTL. 725 THIRD ST. LONDON, ONTARIO N5V 5G4 CA Other 510(k) Applications for this Company
Contact	JOHN STRAATMAN 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	12/27/2005
Decision Date	02/27/2006
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Statement
Type	Special
Reviewed By Third Party	N
Expedited Review