FDA 510(k) Application Details - K953461

Device Classification Name	Valve, Non-Rebreathing   More FDA Info for this Device
510(K) Number	K953461
Device Name	Valve, Non-Rebreathing
Applicant	SAFETEC OF AMERICA, INC. 1055 EAST DELAVAN AVE. BUFFALO, NY 14215 US Other 510(k) Applications for this Company
Contact	ROBERT O DEAN 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	07/24/1995
Decision Date	01/04/1996
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