The following data is part of a premarket notification filed by Surgitek with the FDA for Surgitek Infusion Stent System*.
| Device ID | K872353 |
| 510k Number | K872353 |
| Device Name: | SURGITEK INFUSION STENT SYSTEM* |
| Classification | Stent, Ureteral |
| Applicant | SURGITEK 3037 MT. PLEASANT ST. Racine, WI 53404 |
| Contact | M. S Waxberg |
| Correspondent | M. S Waxberg SURGITEK 3037 MT. PLEASANT ST. Racine, WI 53404 |
| Product Code | FAD |
| CFR Regulation Number | 876.4620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-06-18 |
| Decision Date | 1987-09-16 |