ENDOLED
Led Light Source
OLYMPUS WINTER & IBE GMBH
The following data is part of a premarket notification filed by Olympus Winter & Ibe Gmbh with the FDA for Endoled.
Pre-market Notification Details
| Device ID | K133311 |
| 510k Number | K133311 |
| Device Name: | ENDOLED |
| Classification | Led Light Source |
| Applicant | OLYMPUS WINTER & IBE GMBH 3500 CORPORATE PARKWAY Center Valley, PA 18034 |
| Contact | Sheri L Musgnung |
| Correspondent | Sheri L Musgnung OLYMPUS WINTER & IBE GMBH 3500 CORPORATE PARKWAY Center Valley, PA 18034 |
| Product Code | NTN |
| CFR Regulation Number | 876.1500 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2013-10-28 |
| Decision Date | 2014-07-30 |
| Summary: | summary |
NIH GUDID Devices
| Device Identifier | submissionNumber | Supplement |
|---|---|---|
| 04042761073592 | K133311 | 000 |
| 04042761070010 | K133311 | 000 |
Trademark Results [ENDOLED]
Mark Image Registration | Serial | Company Trademark Application Date |
|---|---|
 ENDOLED 77641574 3775877 Live/Registered |
OLYMPUS CORPORATION 2008-12-30 |
© 2025 FDA.report
This site is not affiliated with or endorsed by the FDA.