510(k) DEN150001
- Device
- RELIZORB
- Applicant
- Alcresta, Inc.
- 510(k) number
- DEN150001
- Product code
- PLQ
- Decision
- Unknown (DENG)
- Decision date
- 2015-11-20
- Date received
- 2015-01-02
- Regulation
- 876.5985
- Classification name
- Enzyme Packed Cartridge
- Medical specialty
- Gastroenterology, Urology
- Review panel
- Gastroenterology, Urology
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- ROBERT GALLOTTO
- Address
- One Newton Executive Park, Suite 202 Newton MA US 02462 02462
FDA Registration Numbers#
- 3007544634
- 3009596666
Source Documents#
510(k) summary PDF not indicated by FDA
Other 510(k) Records For Product Code PLQ#
| 510(k) | Device | Applicant | Decision date |
|---|---|---|---|
| K250499 | RELiZORB (100300/100301) | Alcresta Therapeutics, Inc. | 2025-04-17 |
| K243284 | RELiZORB (100300/ 100301) | Alcresta Therapeutics, Inc. | 2025-01-15 |
| K232784 | RELiZORB® | Alcresta Therapeutics, Inc. | 2023-12-21 |
| K231156 | Enzyme Packed Cartridge - RELiZORB | Alcresta Therapeutics, Inc. | 2023-08-30 |
| K191379 | RELiZORB | Alcresta Therapeutics, Inc. | 2019-12-04 |
| K163057 | Relizorb | Alcresta Therapeutics, Inc. | 2017-07-12 |
| K161247 | Relizorb | Alcresta Therapeutics, Inc. | 2016-06-30 |