FDA 510(k) Application Details - K223821

Device Classification Name	Tray, Catheterization, Sterile Urethral, With Or Without Catheter   More FDA Info for this Device
510(K) Number	K223821
Device Name	Tray, Catheterization, Sterile Urethral, With Or Without Catheter
Applicant	Coloplast 1601 West River Road North Minneapolis, MN 55411 US Other 510(k) Applications for this Company
Contact	Preeti Jain Other 510(k) Applications for this Contact
Regulation Number	876.5130   More FDA Info for this Regulation Number
Classification Product Code	FCM Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/21/2022
Decision Date	08/02/2023
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