The following data is part of a premarket notification filed by Schneider Intl., Ltd. with the FDA for Expandable Biliary Stent Endoprosthesis.
| Device ID | K885180 |
| 510k Number | K885180 |
| Device Name: | EXPANDABLE BILIARY STENT ENDOPROSTHESIS |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | SCHNEIDER INTL., LTD. 2905 NORTHWEST BLVD. Minneapolis, MN 55441 |
| Contact | Alan Marquardt |
| Correspondent | Alan Marquardt SCHNEIDER INTL., LTD. 2905 NORTHWEST BLVD. Minneapolis, MN 55441 |
| Product Code | FGE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-12-14 |
| Decision Date | 1989-02-16 |