The following data is part of a premarket notification filed by Surgitek with the FDA for Ureteral Catheter.
| Device ID | K930483 |
| 510k Number | K930483 |
| Device Name: | URETERAL CATHETER |
| Classification | Catheter, Ureteral, Gastro-urology |
| Applicant | SURGITEK 3037 MT. PLEASANT ST. Racine, WI 53404 |
| Contact | Brian Kunst |
| Correspondent | Brian Kunst SURGITEK 3037 MT. PLEASANT ST. Racine, WI 53404 |
| Product Code | EYB |
| CFR Regulation Number | 876.5130 [🔎] |
| Decision | Substantially Equivalent - Kit (SESK) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-01-29 |
| Decision Date | 1993-07-16 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00821925009875 | K930483 | 000 |