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 IDK133311
510k NumberK133311
Device Name:ENDOLED
ClassificationLed Light Source
Applicant OLYMPUS WINTER & IBE GMBH 3500 CORPORATE PARKWAY Center Valley,  PA  18034
ContactSheri L Musgnung
CorrespondentSheri L Musgnung
OLYMPUS WINTER & IBE GMBH 3500 CORPORATE PARKWAY Center Valley,  PA  18034
Product CodeNTN  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2013-10-28
Decision Date2014-07-30
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
04042761073592 K133311 000
04042761070010 K133311 000

Trademark Results [ENDOLED]

Mark Image

Registration | Serial
Company
Trademark
Application Date
ENDOLED
ENDOLED
77641574 3775877 Live/Registered
OLYMPUS CORPORATION
2008-12-30

© 2024 FDA.report
This site is not affiliated with or endorsed by the FDA.