The following data is part of a premarket notification filed by Surgitek with the FDA for Surgitek All Silicone Infection Doubj.
| Device ID | K833782 |
| 510k Number | K833782 |
| Device Name: | SURGITEK ALL SILICONE INFECTION DOUBJ |
| Classification | Stent, Ureteral |
| Applicant | SURGITEK 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FAD |
| CFR Regulation Number | 876.4620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-10-28 |
| Decision Date | 1984-04-02 |