The following data is part of a premarket notification filed by Olympus Medical Systems Corp. with the FDA for Single Use Biliary Balloon Dilator.
| Device ID | K143303 |
| 510k Number | K143303 |
| Device Name: | Single Use Biliary Balloon Dilator |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | OLYMPUS MEDICAL SYSTEMS CORP. 2951 ISHIKAWA-CHO Hachioji, JP 192-8507 |
| Contact | Sheri Musgnung |
| Correspondent | Sheri L Musgnung OLYMPUS CORPORATION OF THE AMERICAS 3500 CORPORATE PARKWAY PO BOX 610 Center Valley, PA 18034 -0610 |
| Product Code | FGE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2014-11-18 |
| Decision Date | 2015-02-27 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 14953170400022 | K143303 | 000 |
| 14953170372275 | K143303 | 000 |
| 14953170372299 | K143303 | 000 |
| 14953170372312 | K143303 | 000 |
| 14953170372336 | K143303 | 000 |
| 14953170399982 | K143303 | 000 |
| 14953170399999 | K143303 | 000 |
| 14953170400008 | K143303 | 000 |
| 14953170400015 | K143303 | 000 |
| 14953170372251 | K143303 | 000 |