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PLQ — Enzyme Packed Cartridge Class II

FDA Device Classification

Classification Details

Product Code
PLQ
Device Class
Class II
Regulation Number
876.5985
Submission Type
Review Panel
GU
Medical Specialty
Gastroenterology, Urology
Implant
No

Definition

Hydrolyze fats in enteral formula.

Recent 510(k) Clearances

K-NumberApplicantDevice NameDate
K250499alcresta therapeuticsRELiZORB (100300/100301)April 17, 2025
K243284alcresta therapeuticsRELiZORB (100300/ 100301)January 15, 2025
K232784alcresta therapeuticsRELiZORB®December 21, 2023
K231156alcresta therapeuticsEnzyme Packed Cartridge - RELiZORBAugust 30, 2023
K191379alcresta therapeuticsRELiZORBDecember 4, 2019
K163057alcresta therapeuticsRelizorbJuly 12, 2017
K161247alcresta therapeuticsRelizorbJune 30, 2016
DEN150001alcrestaRELIZORBNovember 20, 2015