Home / 510(k) Clearances / K250499

510(k) K250499

RELiZORB (100300/100301) by Alcresta Therapeutics, Inc. — Product Code PLQ

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: April 17, 2025
Date Received: February 20, 2025
Clearance Type: Traditional
Expedited Review: No
Third Party Review: No

Device Classification

Device Name: Enzyme Packed Cartridge
Device Class: Class II
Regulation Number: 876.5985
Review Panel: GU
Submission Type

Hydrolyze fats in enteral formula.