The following data is part of a premarket notification filed by Olympus Winter & Ibe Gmbh with the FDA for Ultra Telescopes.
| Device ID | K160249 |
| 510k Number | K160249 |
| Device Name: | ULTRA Telescopes |
| Classification | Arthroscope |
| Applicant | Olympus Winter & Ibe GmbH Kuehnstr. 61 Hamburg, DE 22045 |
| Contact | Katharina Campbell |
| Correspondent | Sheri L. Musgnung Olympus Corporation Of The Americas 3500 Corporate Parkway Center Valley, PA 18034 |
| Product Code | HRX |
| CFR Regulation Number | 888.1100 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2016-02-01 |
| Decision Date | 2016-04-21 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04042761083027 | K160249 | 000 |
| 04042761083010 | K160249 | 000 |
| 04042761083003 | K160249 | 000 |