FDA 510(k) Application Details - K010450

Device Classification Name	Balloon, Liver Tamponade   More FDA Info for this Device
510(K) Number	K010450
Device Name	Balloon, Liver Tamponade
Applicant	COOK, INC. 925 SOUTH CURRY PIKE P.O. BOX 489 BLOOMINGTON, IN 47402 US Other 510(k) Applications for this Company
Contact	LISA HOPKINS Other 510(k) Applications for this Contact
Regulation Number	876.5980   More FDA Info for this Regulation Number
Classification Product Code	NGU Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	02/15/2001
Decision Date	09/06/2001
Decision	SESE - SUBST EQUIV
Classification Advisory Committee	GU - Gastroenterology & Urology
Review Advisory Committee	SU - General & Plastic Surgery
Statement / Summary / Purged Status	Summary
Type	Traditional
Reviewed By Third Party	N
Expedited Review