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510(k) K191379

RELiZORB by Alcresta Therapeutics, Inc. — Product Code PLQ

Clearance Details

Decision: SESE (Substantially Equivalent)
Decision Date: December 4, 2019
Date Received: May 23, 2019
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.