The following data is part of a premarket notification filed by Surgitek with the FDA for Urethral Obstruct Primary Exchange Sten.
| Device ID | K832915 |
| 510k Number | K832915 |
| Device Name: | URETHRAL OBSTRUCT PRIMARY EXCHANGE STEN |
| Classification | Stent, Ureteral |
| Applicant | SURGITEK 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | FAD |
| CFR Regulation Number | 876.4620 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1983-08-29 |
| Decision Date | 1983-10-14 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 00821925007192 | K832915 | 000 |
| 00821925005563 | K832915 | 000 |
| 00821925005518 | K832915 | 000 |
| 00821925005372 | K832915 | 000 |
| 00821925005365 | K832915 | 000 |
| 00821925001596 | K832915 | 000 |
| 00821925001589 | K832915 | 000 |
| 00821925001558 | K832915 | 000 |
| 00821925001466 | K832915 | 000 |
| 00821925006058 | K832915 | 000 |
| 00821925006355 | K832915 | 000 |
| 00821925006751 | K832915 | 000 |
| 00821925007130 | K832915 | 000 |
| 00821925007123 | K832915 | 000 |
| 00821925007109 | K832915 | 000 |
| 00821925007086 | K832915 | 000 |
| 00821925007079 | K832915 | 000 |
| 00821925006904 | K832915 | 000 |
| 00821925006898 | K832915 | 000 |
| 00821925006850 | K832915 | 000 |
| 00821925001084 | K832915 | 000 |