The following data is part of a premarket notification filed by Menlo Care, Inc. with the FDA for Biliary Stent.
| Device ID | K943143 |
| 510k Number | K943143 |
| Device Name: | BILIARY STENT |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | MENLO CARE, INC. 1350 WILLOW RD. Menlo Park, CA 94025 -1516 |
| Contact | Bob Bley |
| Correspondent | Bob Bley MENLO CARE, INC. 1350 WILLOW RD. Menlo Park, CA 94025 -1516 |
| Product Code | FGE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-06-30 |
| Decision Date | 1995-02-28 |