The following data is part of a premarket notification filed by Princeton Regulatory Assoc. with the FDA for Urosurge Urostent.
| Device ID | K973504 |
| 510k Number | K973504 |
| Device Name: | UROSURGE UROSTENT |
| Classification | Stent, Ureteral |
| Applicant | PRINCETON REGULATORY ASSOC. 116 VILLAGE BLVD., SUITE 200 Princeton, NJ 08540 -5799 |
| Contact | Thomas Becze |
| Correspondent | Thomas Becze PRINCETON REGULATORY ASSOC. 116 VILLAGE BLVD., SUITE 200 Princeton, NJ 08540 -5799 |
| Product Code | FAD |
| CFR Regulation Number | 876.4620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-09-16 |
| Decision Date | 1998-01-30 |