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510(k) DEN150001

RELIZORB by Alcresta, Inc. — Product Code PLQ

Clearance Details

Decision: DENG (De Novo Granted)
Decision Date: November 20, 2015
Date Received: January 2, 2015
Clearance Type: Direct
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.