The following data is part of a premarket notification filed by Olympus Winter & Ibe Gmbh with the FDA for Hd Endoeye, Models Wa50011a, Wa50013a, Wa50013l, Wa50013t, Wa50015l.
| Device ID | K090980 |
| 510k Number | K090980 |
| Device Name: | HD ENDOEYE, MODELS WA50011A, WA50013A, WA50013L, WA50013T, WA50015L |
| Classification | Endoscope, Accessories, Narrow Band Spectrum |
| Applicant | OLYMPUS WINTER & IBE GMBH 3500 CORPORATE PKWAY PO BOX 610 Center Valley, PA 18034 -0610 |
| Contact | Stacy A Kuesner |
| Correspondent | Stacy A Kuesner OLYMPUS WINTER & IBE GMBH 3500 CORPORATE PKWAY PO BOX 610 Center Valley, PA 18034 -0610 |
| Product Code | NWB |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2009-04-07 |
| Decision Date | 2009-06-29 |
| Summary: | summary |
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04042761062114 | K090980 | 000 |
| 04042761062091 | K090980 | 000 |
| 04042761061957 | K090980 | 000 |
| 04042761061728 | K090980 | 000 |