FDA 510(k) Application Details - K955520

Device Classification Name	Valve, Non-Rebreathing   More FDA Info for this Device
510(K) Number	K955520
Device Name	Valve, Non-Rebreathing
Applicant	INTERNATIONAL SAFETY, INC. 2322 DOUGLAS DR. EUGENE, OR 97405 US Other 510(k) Applications for this Company
Contact	ROBERT S MCQUATE 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	12/04/1995
Decision Date	10/08/1996
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	AN - Anesthesiology
Review Advisory Committee	AN - Anesthesiology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review