The following data is part of a premarket notification filed by Schneider Intl., Ltd. with the FDA for Biliary Endoprostheses W/unistep Delivery System.
| Device ID | K925406 |
| 510k Number | K925406 |
| Device Name: | BILIARY ENDOPROSTHESES W/UNISTEP DELIVERY SYSTEM |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | SCHNEIDER INTL., LTD. 5905 NATHAN LN. Plymouth, MN 55442 |
| Contact | Amy Peterson |
| Correspondent | Amy Peterson SCHNEIDER INTL., LTD. 5905 NATHAN LN. Plymouth, MN 55442 |
| Product Code | FGE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-10-26 |
| Decision Date | 1995-01-11 |