The following data is part of a premarket notification filed by Medical Engineering Corp. with the FDA for Surgitek(r) Lubri-flex(tm) Ureteral Stent.
| Device ID | K905289 |
| 510k Number | K905289 |
| Device Name: | SURGITEK(R) LUBRI-FLEX(TM) URETERAL STENT |
| Classification | Stent, Ureteral |
| Applicant | MEDICAL ENGINEERING CORP. 3037 MT. PLEASANT ST. Racine, WI 53404 |
| Contact | Steve Aperavich |
| Correspondent | Steve Aperavich 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 | 1990-11-26 |
| Decision Date | 1991-03-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00821925006935 | K905289 | 000 |
| 00821925004139 | K905289 | 000 |
| 00821925004092 | K905289 | 000 |
| 00821925004078 | K905289 | 000 |
| 00821925003989 | K905289 | 000 |
| 00821925003972 | K905289 | 000 |
| 00821925003903 | K905289 | 000 |
| 00821925003880 | K905289 | 000 |
| 00821925003576 | K905289 | 000 |
| 00821925003125 | K905289 | 000 |
| 00821925003088 | K905289 | 000 |
| 00821925003033 | K905289 | 000 |
| 00821925003026 | K905289 | 000 |
| 00821925002340 | K905289 | 000 |
| 00821925001473 | K905289 | 000 |
| 00821925004153 | K905289 | 000 |
| 00821925004177 | K905289 | 000 |
| 00821925006737 | K905289 | 000 |
| 00821925004849 | K905289 | 000 |
| 00821925004764 | K905289 | 000 |
| 00821925004733 | K905289 | 000 |
| 00821925004672 | K905289 | 000 |
| 00821925004665 | K905289 | 000 |
| 00821925004580 | K905289 | 000 |
| 00821925004573 | K905289 | 000 |
| 00821925004535 | K905289 | 000 |
| 00821925004511 | K905289 | 000 |
| 00821925004467 | K905289 | 000 |
| 00821925004450 | K905289 | 000 |
| 00821925004412 | K905289 | 000 |
| 00821925004306 | K905289 | 000 |
| 00821925001138 | K905289 | 000 |