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 Code | PLQ |
Premarket Review |
Renal, Gastrointestinal, Obesity and Transplant Devices
(DHT3A)
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 |
|
|