FDA 510(k) Application Details - K240057

Device Classification Name	Catheter, Retention Type, Balloon   More FDA Info for this Device
510(K) Number	K240057
Device Name	Catheter, Retention Type, Balloon
Applicant	Sentinel Medical Technologies, LLC 50 N Laura St. Suite 2500 Jacksonville, FL 32202 US Other 510(k) Applications for this Company
Contact	Robert Mueller 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	01/08/2024
Decision Date	04/17/2024
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