The following data is part of a premarket notification filed by Olympus Corp. with the FDA for Olympus Pbd Stents.
| Device ID | K933200 |
| 510k Number | K933200 |
| Device Name: | OLYMPUS PBD STENTS |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | OLYMPUS CORP. 4 NEVADA DR. Lake Success, NY 11042 |
| Contact | Barry E Sands |
| Correspondent | Barry E Sands OLYMPUS CORP. 4 NEVADA DR. Lake Success, NY 11042 |
| Product Code | FGE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-07-01 |
| Decision Date | 1995-04-05 |