The following data is part of a premarket notification filed by Olympus Winter & Ibe Gmbh with the FDA for Ultra Telescopes.
| Device ID | K150633 |
| 510k Number | K150633 |
| Device Name: | ULTRA Telescopes |
| Classification | Laparoscope, General & Plastic Surgery |
| Applicant | OLYMPUS WINTER & IBE GMBH KUEHNSTRASSE 61 Hamburg, DE 22045 |
| Contact | Katharina Schnackenburg |
| Correspondent | Sheri L. Musgnung OLYMPUS CORPORTION OF THE AMERICAS 3500 CORPORATE PARKWAY Center Valley, PA 18034 |
| Product Code | GCJ |
| Subsequent Product Code | HET |
| Subsequent Product Code | NMH |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-03-11 |
| Decision Date | 2015-04-29 |
| Summary: | summary |