The following data is part of a De Novo classification by Alcresta, Inc. with the FDA for Relizorb.
| DeNovo ID | DEN150001 |
| Device Name: | RELIZORB |
| Classification | Enzyme Packed Cartridge |
| Applicant | ALCRESTA, INC. one Newton Executive Park, Suite 202 Newton, MA 02462 |
| Contact | Robert Gallotto |
| Product Code | PLQ |
| CFR Regulation Number | 876.5985 [🔎] |
| Decision | Granted (DENG) |
| 510(k) Premarket Notification | Device Classification Under Section 513(f)(2)(De Novo) // Quick Links: Skip To Main Page Content Skip To Search Skip To Topics Menu Skip To Common Lin |
| Review Advisory Board | Gastroenterology/Urology |
| Classification Advisory | Gastroenterology/Urology |
| Type | Direct |
| Date Received | 2015-01-02 |
| Decision Date | 2015-11-20 |
| FDA Review | Decision Summary |
| Reclassification Order: | Reclassification Order |