FDA 510(k) Application Details - K223890

Device Classification Name	Catheter, Retention, Barium Enema With Bag   More FDA Info for this Device
510(K) Number	K223890
Device Name	Catheter, Retention, Barium Enema With Bag
Applicant	Chess Medical Inc. 1650 Sherbrooke Street West, Suite 9E Montreal H3H 1C9 CA Other 510(k) Applications for this Company
Contact	Dr. Yen-I Chen Other 510(k) Applications for this Contact
Regulation Number	876.5980   More FDA Info for this Regulation Number
Classification Product Code	FGD Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	12/27/2022
Decision Date	06/16/2023
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