The following data is part of a premarket notification filed by Surgitek with the FDA for Metal Tipped Ureter. Stent & Magnetic Stent Retri..
| Device ID | K863492 |
| 510k Number | K863492 |
| Device Name: | METAL TIPPED URETER. STENT & MAGNETIC STENT RETRI. |
| Classification | Stent, Ureteral |
| Applicant | SURGITEK 3037 MT. PLEASANT ST. Racine, WI 53404 |
| Contact | Betty A Lock |
| Correspondent | Betty A Lock 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 | 1986-09-09 |
| Decision Date | 1986-12-18 |