LINVATEC 300W XENON LIGHT SOURCE

Light Source, Endoscope, Xenon Arc

LINVATEC CORP.

The following data is part of a premarket notification filed by Linvatec Corp. with the FDA for Linvatec 300w Xenon Light Source.

Pre-market Notification Details

Device IDK031994
510k NumberK031994
Device Name:LINVATEC 300W XENON LIGHT SOURCE
ClassificationLight Source, Endoscope, Xenon Arc
Applicant LINVATEC CORP. 11311 CONCEPT BLVD. Largo,  FL  33773 -4908
ContactLaura D Krejci
CorrespondentLaura D Krejci
LINVATEC CORP. 11311 CONCEPT BLVD. Largo,  FL  33773 -4908
Product CodeGCT  
CFR Regulation Number876.1500 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2003-06-27
Decision Date2003-08-21
Summary:summary

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