The following data is part of a premarket notification filed by Olympus America, Inc. with the FDA for Olympus Nbd Tubes.
| Device ID | K944912 |
| 510k Number | K944912 |
| Device Name: | OLYMPUS NBD TUBES |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | OLYMPUS AMERICA, INC. 4 NEVADA DR. Lake Success, NY 11042 -1179 |
| Contact | Barry E Sands |
| Correspondent | Barry E Sands OLYMPUS AMERICA, INC. 4 NEVADA DR. Lake Success, NY 11042 -1179 |
| Product Code | FGE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-10-05 |
| Decision Date | 1995-06-13 |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 14953170309592 | K944912 | 000 |
| 14953170309332 | K944912 | 000 |
| 14953170309356 | K944912 | 000 |
| 14953170309370 | K944912 | 000 |
| 14953170309394 | K944912 | 000 |
| 14953170309417 | K944912 | 000 |
| 14953170309431 | K944912 | 000 |
| 14953170309455 | K944912 | 000 |
| 14953170309479 | K944912 | 000 |
| 14953170309493 | K944912 | 000 |
| 14953170309516 | K944912 | 000 |
| 14953170309530 | K944912 | 000 |
| 14953170309554 | K944912 | 000 |
| 14953170309578 | K944912 | 000 |
| 14953170309318 | K944912 | 000 |