FDA 510(k) Application Details - K003402

Device Classification Name	Catheter And Tip, Suction   More FDA Info for this Device
510(K) Number	K003402
Device Name	Catheter And Tip, Suction
Applicant	WELCON, INC. 5 WHITCOMB AVE. AYER, MA 01432 US Other 510(k) Applications for this Company
Contact	PAMELA PAPINEAU 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	11/01/2000
Decision Date	05/01/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	HO - General Hospital
Review Advisory Committee	HO - General Hospital
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review