FDA 510(k) Application Details - K011134

Device Classification Name	Tubing, Pressure And Accessories   More FDA Info for this Device
510(K) Number	K011134
Device Name	Tubing, Pressure And Accessories
Applicant	HUDSON RESPIRATORY CARE, INC. 27711 DIAZ RD. P.O. BOX 9020 TEMECULA, CA 92589-9020 US Other 510(k) Applications for this Company
Contact	JEANNIE K DENNING Other 510(k) Applications for this Contact
Regulation Number	868.5860   More FDA Info for this Regulation Number
Classification Product Code	BYX Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/13/2001
Decision Date	06/13/2001
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