FDA 510(k) Application Details - K231156

Device Classification Name	More FDA Info for this Device
510(K) Number	K231156
Device Name	Enzyme Packed Cartridge - RELiZORB
Applicant	Alcresta Therapeutics, Inc. 130 Turner Street, Building 3, Suite 200 Waltham, MA 02453 US Other 510(k) Applications for this Company
Contact	Matthew King Other 510(k) Applications for this Contact
Regulation Number	More FDA Info for this Regulation Number
Classification Product Code	PLQ Other 510(k) Applications for this Device   More FDA Info for this Product Code
Date Received	04/24/2023
Decision Date	08/30/2023
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