FDA 510(k) Application Details - K233411

Device Classification Name	Catheter, Retention Type, Balloon   More FDA Info for this Device
510(K) Number	K233411
Device Name	Catheter, Retention Type, Balloon
Applicant	Coloplast Corp 1601 West River Road North Minneapolis, MN 55411 US Other 510(k) Applications for this Company
Contact	Brian Schmidt 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	10/06/2023
Decision Date	04/15/2024
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