FDA 510(k) Application Details - K960401

Device Classification Name	Mask, Oxygen, Non-Rebreathing   More FDA Info for this Device
510(K) Number	K960401
Device Name	Mask, Oxygen, Non-Rebreathing
Applicant	HANS RUDOLPH, INC. 7200 WYANDOTTE KANSAS CITY, MO 64114 US Other 510(k) Applications for this Company
Contact	KEVIN RUDOLPH Other 510(k) Applications for this Contact
Regulation Number	868.5570   More FDA Info for this Regulation Number
Classification Product Code	KGB Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	01/29/1996
Decision Date	06/20/1996
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review