FDA 510(k) Application Details - K962872

Device Classification Name	Nebulizer (Direct Patient Interface)   More FDA Info for this Device
510(K) Number	K962872
Device Name	Nebulizer (Direct Patient Interface)
Applicant	TYCO HEALTHCARE DEUTSCHALAND GMBH RAFFINERIESTR. 18 NEUSTADT A D DONAU D-93333 DE Other 510(k) Applications for this Company
Contact	WILLIAM D CURTIN 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	07/23/1996
Decision Date	02/25/1997
Decision	SESD - SUBST EQUIV - WITH DRUG
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review