FDA 510(k) Application Details - K231101

Device Classification Name	Catheter, Retention Type, Balloon   More FDA Info for this Device
510(K) Number	K231101
Device Name	Catheter, Retention Type, Balloon
Applicant	Flume Catheter Company, Ltd. The Granary, Milhouse Farnham GU10 3EE GB Other 510(k) Applications for this Company
Contact	Roger Holmes Other 510(k) Applications for this Contact
Regulation Number	876.5130   More FDA Info for this Regulation Number
Classification Product Code	EZL Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/18/2023
Decision Date	06/29/2023
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