The following data is part of a premarket notification filed by Olympus Winter & Ibe Gmbh with the FDA for Olympus Video Ureteroscope, Ntsc.
| Device ID | K033651 |
| 510k Number | K033651 |
| Device Name: | OLYMPUS VIDEO URETEROSCOPE, NTSC |
| Classification | Ureteroscope And Accessories, Flexible/rigid |
| Applicant | OLYMPUS WINTER & IBE GMBH TWO CORPORATE CENTER DR. Melville, NY 11747 -3157 |
| Contact | Tina Steffanie-oak |
| Correspondent | Tina Steffanie-oak OLYMPUS WINTER & IBE GMBH TWO CORPORATE CENTER DR. Melville, NY 11747 -3157 |
| Product Code | FGB |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Special |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2003-11-20 |
| Decision Date | 2004-01-30 |
| Summary: | summary |