The following data is part of a premarket notification filed by Olympus Winter & Ibe Gmbh with the FDA for Single Use Balloon Dilator Maxpasstm.
| Device ID | K050502 |
| 510k Number | K050502 |
| Device Name: | SINGLE USE BALLOON DILATOR MAXPASSTM |
| Classification | Stents, Drains And Dilators For The Biliary Ducts |
| Applicant | OLYMPUS WINTER & IBE GMBH TWO CORPORATE CENTER DR. Melville, NY 11747 -3157 |
| Contact | Laura Storms-tyler |
| Correspondent | Laura Storms-tyler OLYMPUS WINTER & IBE GMBH TWO CORPORATE CENTER DR. Melville, NY 11747 -3157 |
| Product Code | FGE |
| CFR Regulation Number | 876.5010 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-02-28 |
| Decision Date | 2005-07-08 |
| Summary: | summary |