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U.S. Department of Health and Human Services

Product Classification
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Device enzyme packed cartridge
Regulation Description Enzyme packed cartridge.
Definition Hydrolyze fats in enteral formula.
Physical State Cartridge packed with enzyme linked beads
Technical Method Hydrolyzes fats in enteral formula ex vivo and delivers them into the enteral tract through a feeding tube
Target Area GI tract
Regulation Medical Specialty Gastroenterology/Urology
Review Panel Gastroenterology/Urology
Product CodePLQ
Premarket Review Office of Gastrorenal, ObGyn, General Hospital, and Urology Devices (OHT3)
Renal, Gastrointestinal, Obesity and Transplant Devices (DHT3A)
Submission Type 510(k)
Regulation Number 876.5985
Device Class 2
Total Product Life Cycle (TPLC) TPLC Product Code Report
GMP Exempt? No
Summary Malfunction
Reporting		 Eligible
Implanted Device? No
Life-Sustain/Support Device? No
Third Party Review Not Third Party Eligible
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