FDA 510(k) Application Details - K043258

Device Classification Name	Tubes, Gastrointestinal (And Accessories)   More FDA Info for this Device
510(K) Number	K043258
Device Name	Tubes, Gastrointestinal (And Accessories)
Applicant	TELEFLEX MEDICAL 50 PLANTATION DRIVE TALL PINES PARK JAFFERY, NH 03452 US Other 510(k) Applications for this Company
Contact	SUSAN KAGAN Other 510(k) Applications for this Contact
Regulation Number	876.5980   More FDA Info for this Regulation Number
Classification Product Code	KNT Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	11/24/2004
Decision Date	12/16/2004
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Special
Reviewed By Third Party	N
Expedited Review