FDA 510(k) Application Details - K970780

Device Classification Name	Valve, Non-Rebreathing   More FDA Info for this Device
510(K) Number	K970780
Device Name	Valve, Non-Rebreathing
Applicant	INSTRUMENTATION INDUSTRIES, INC. 2990 INDUSTRIAL BLVD. BETHEL PARK, PA 15102 US Other 510(k) Applications for this Company
Contact	LORI ZURAVLEFF 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	03/04/1997
Decision Date	09/18/1997
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