FDA 510(k) Application Details - K000265

Device Classification Name	Catheter And Tip, Suction   More FDA Info for this Device
510(K) Number	K000265
Device Name	Catheter And Tip, Suction
Applicant	PRIMARY CARE SOLUTIONS, INC. 339 STONETOWN RD. RINGWOOD, NJ 07456 US Other 510(k) Applications for this Company
Contact	NORMAN RUEDT 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	01/28/2000
Decision Date	07/12/2001
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