Definition: Hydrolyze Fats In Enteral Formula.
| Device Type ID | 2108 |
| Device Name | Enzyme Packed Cartridge |
| 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 Description | Enzyme Packed Cartridge. |
| Regulation Medical Specialty | Gastroenterology/Urology |
| Review Panel | Gastroenterology/Urology |
| Premarket Review | Office Of Device Evaluation (ODE) Division Of Reproductive, Gastro-Renal, And Urological Devices (DRGUD) Gastroenterology Devices Branch (GEDB) |
| Submission Type | 510(k) |
| CFR Regulation Number | 876.5985 [🔎] |
| FDA Device Classification | Class 2 Medical Device |
| Product Code | PLQ |
| GMP Exempt | No |
| Summary MR | Eligible |
| Implanted Device | No |
| Life Support Device | No |
| Third Party Review | Not Third Party Eligible |
| Device Type ID | 2108 |
| Device | Enzyme Packed Cartridge |
| Product Code | PLQ |
| FDA Device Classification | Class 2 Medical Device |
| Regulation Description | Enzyme Packed Cartridge. |
| CFR Regulation Number | 876.5985 [🔎] |
| Premarket Reviews | ||
|---|---|---|
| Manufacturer | Decision | |
ALCRESTA THERAPEUTICS, INC. | ||
SUBSTANTIALLY EQUIVALENT | 2 | |