FDA 510(k) Application Details - K974758

Device Classification Name	Catheter And Tip, Suction   More FDA Info for this Device
510(K) Number	K974758
Device Name	Catheter And Tip, Suction
Applicant	HYDROX LABORATORIES 825 B TOLLGATE RD. ELGIN, IL 60123 US Other 510(k) Applications for this Company
Contact	KAPPANA RAMANANDAN Other 510(k) Applications for this Contact
Regulation Number	880.6740   More FDA Info for this Regulation Number
Classification Product Code	JOL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/19/1997
Decision Date	03/09/1998
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Statement
Type	Traditional
Reviewed By Third Party	N
Expedited Review