FDA 510(k) Application Details - K250499

Device Classification Name	More FDA Info for this Device
510(K) Number	K250499
Device Name	RELiZORB (100300/100301)
Applicant	Alcresta Therapeutics, Inc 130 Turner Street Building 3, Suite 200 Waltham, MA 02453 US Other 510(k) Applications for this Company
Contact	Daniel Orlando 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	02/20/2025
Decision Date	04/17/2025
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