The following data is part of a premarket notification filed by Urogen Pharma Ltd with the FDA for Cystoject Syringe Lever.
| Device ID | K203321 |
| 510k Number | K203321 |
| Device Name: | Cystoject Syringe Lever |
| Classification | Piston Syringe Lever |
| Applicant | UroGen Pharma Ltd 9 Ha'Ta'asiya Street Ra'anana, IL 4365405 |
| Contact | James G. Ottinger |
| Correspondent | James G. Ottinger UroGen Pharma Inc 400 Alexander Park Drive Princeton, NJ 08540 |
| Product Code | QBL |
| CFR Regulation Number | 880.5860 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2020-11-12 |
| Decision Date | 2020-12-09 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 20854913006048 | K203321 | 000 |