The following data is part of a premarket notification filed by Surgitek Medical Engineering Corp. with the FDA for Surgitek(r) 4.5fr Lubri-flex(tm) Ureteral Stent.
| Device ID | K913928 |
| 510k Number | K913928 |
| Device Name: | SURGITEK(R) 4.5FR LUBRI-FLEX(TM) URETERAL STENT |
| Classification | Stent, Ureteral |
| Applicant | SURGITEK MEDICAL ENGINEERING CORP. 3037 MT. PLEASANT ST. Racine, WI 53404 |
| Contact | William H Duffell |
| Correspondent | William H Duffell SURGITEK MEDICAL ENGINEERING CORP. 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 | 1991-09-03 |
| Decision Date | 1991-11-19 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00821925006645 | K913928 | 000 |
| 00821925001121 | K913928 | 000 |
| 00821925002067 | K913928 | 000 |
| 00821925003415 | K913928 | 000 |
| 00821925004009 | K913928 | 000 |
| 00821925004085 | K913928 | 000 |
| 00821925004382 | K913928 | 000 |
| 00821925004498 | K913928 | 000 |
| 00821925004566 | K913928 | 000 |
| 00821925006621 | K913928 | 000 |
| 00821925001060 | K913928 | 000 |