LED LIGHT SOURCE

Light Source, Fiberoptic, Routine

SUNOPTIC TECHNOLOGIES, LLC

The following data is part of a premarket notification filed by Sunoptic Technologies, Llc with the FDA for Led Light Source.

Pre-market Notification Details

Device IDK093792
510k NumberK093792
Device Name:LED LIGHT SOURCE
ClassificationLight Source, Fiberoptic, Routine
Applicant SUNOPTIC TECHNOLOGIES, LLC 6018 BOWDENDALE AVE. Jacksonville,  FL  32216 -6042
ContactJanice G Lee
CorrespondentJanice G Lee
SUNOPTIC TECHNOLOGIES, LLC 6018 BOWDENDALE AVE. Jacksonville,  FL  32216 -6042
Product CodeFCW  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2009-12-10
Decision Date2010-03-18
Summary:summary

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00843059116694 K093792 000
04961333240494 K093792 000
04961333233977 K093792 000
04961333231096 K093792 000
00843059112351 K093792 000

Trademark Results [LED LIGHT SOURCE]

Mark Image

Registration | Serial
Company
Trademark
Application Date
LED LIGHT SOURCE
LED LIGHT SOURCE
79200359 5243529 Live/Registered
Maxell Holdings, Ltd.
2016-09-01

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