FDA 510(k) Application Details - K003078

Device Classification Name	Bag, Bile Collecting   More FDA Info for this Device
510(K) Number	K003078
Device Name	Bag, Bile Collecting
Applicant	MERIT MEDICAL SYSTEMS, INC. 1600 WEST MERIT PKWY. SOUTH JORDAN, UT 84095 US Other 510(k) Applications for this Company
Contact	CHESTER MCCOY Other 510(k) Applications for this Contact
Regulation Number	876.5010   More FDA Info for this Regulation Number
Classification Product Code	EXF Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	10/03/2000
Decision Date	12/11/2000
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	GU - Gastroenterology & Urology
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review