The following data is part of a premarket notification filed by Olympus Winter & Ibe Gmbh with the FDA for Endoled.
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 |
Device Identifier | submissionNumber | Supplement |
---|---|---|
04042761073592 | K133311 | 000 |
04042761070010 | K133311 | 000 |
Mark Image Registration | Serial | Company Trademark Application Date |
---|---|
ENDOLED 77641574 3775877 Live/Registered |
OLYMPUS CORPORATION 2008-12-30 |