The following data is part of a premarket notification filed by Olympus, Winter & Ibe Gmbh with the FDA for Ultra Telescopes.
| Device ID | K153009 |
| 510k Number | K153009 |
| Device Name: | ULTRA Telescopes |
| Classification | Nasopharyngoscope (flexible Or Rigid) |
| Applicant | OLYMPUS, WINTER & IBE GMBH KUEHNSTR. 61 Hamburg, DE 22045 |
| Contact | Katharina Schnackenburg |
| Correspondent | Sheri L. Musgnung OLYMPUS CORPORATION OF THE AMERICAS 3500 CORPORATE PARKWAY Center Valley, PA 18034 |
| Product Code | EOB |
| CFR Regulation Number | 874.4760 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2015-10-14 |
| Decision Date | 2016-04-05 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04042761083096 | K153009 | 000 |
| 04042761083089 | K153009 | 000 |
| 04042761083072 | K153009 | 000 |
| 04042761083065 | K153009 | 000 |
| 04042761083058 | K153009 | 000 |
| 04042761083041 | K153009 | 000 |
| 04042761083034 | K153009 | 000 |