FDA 510(k) Application Details - K960995

Device Classification Name	Valve, Non-Rebreathing   More FDA Info for this Device
510(K) Number	K960995
Device Name	Valve, Non-Rebreathing
Applicant	O-TWO SYSTEMS INTL., INC. 7575 KIMBEL ST., UNIT 5 MISSISSAUGA ONTARIO L5S 1C8 CA Other 510(k) Applications for this Company
Contact	KEVIN BOWDEN Other 510(k) Applications for this Contact
Regulation Number	868.5870   More FDA Info for this Regulation Number
Classification Product Code	CBP Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	03/12/1996
Decision Date	01/07/1997
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