The following data is part of a premarket notification filed by Olympus Winter & Ibe Gmbh with the FDA for Oes Elite Telescopes, Protective Tube.
| Device ID | K151191 |
| 510k Number | K151191 |
| Device Name: | OES ELITE Telescopes, Protective Tube |
| Classification | Telescope, Rigid, Endoscopic |
| Applicant | OLYMPUS WINTER & IBE GMBH KUEHNESTRASSE 61 Hamburg, DE 22045 |
| Contact | Katharina Schnackenburg |
| Correspondent | Daphney Germain-kolawole OLYMPUS CORPORATION OF THE AMERICAS 3500 CORPORATE PARKWAY Center Valley, PA 18034 |
| Product Code | FBP |
| Subsequent Product Code | FGC |
| Subsequent Product Code | HIH |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-05-04 |
| Decision Date | 2015-11-24 |
| Summary: | summary |