FDA 510(k) Application Details - K032972

Device Classification Name	Nebulizer (Direct Patient Interface)   More FDA Info for this Device
510(K) Number	K032972
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	TOM HOLBROOK 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	09/24/2003
Decision Date	01/14/2004
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