RELiZORB
Enzyme Packed Cartridge
Alcresta Therapeutics, Inc.
The following data is part of a premarket notification filed by Alcresta Therapeutics, Inc. with the FDA for Relizorb.
Pre-market Notification Details
| Device ID | K191379 |
| 510k Number | K191379 |
| Device Name: | RELiZORB |
| Classification | Enzyme Packed Cartridge |
| Applicant | Alcresta Therapeutics, Inc. One Newton Executive Park, Suite 100 Newton, MA 02462 |
| Contact | Eric First |
| Correspondent | Nandini Murthy Alcresta Therapeutics, Inc. One Newton Executive Park, Suite 100 Newton, MA 02462 |
| Product Code | PLQ |
| CFR Regulation Number | 876.5985 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2019-05-23 |
| Decision Date | 2019-12-04 |
Trademark Results [RELiZORB]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 RELIZORB 86690981 5087672 Live/Registered |
ALCRESTA THERAPEUTICS, INC. 2015-07-13 |
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