ENDOVASCULAR LASER VEIN SYSTEM KIT

Powered Laser Surgical Instrument

BIOLITEC MEDICAL DEVICES, INC

The following data is part of a premarket notification filed by Biolitec Medical Devices, Inc with the FDA for Endovascular Laser Vein System Kit.

Pre-market Notification Details

Device IDK112299
510k NumberK112299
Device Name:ENDOVASCULAR LASER VEIN SYSTEM KIT
ClassificationPowered Laser Surgical Instrument
Applicant BIOLITEC MEDICAL DEVICES, INC 1349 MAIN ROAD Grandville,  MA  01034
ContactHarry Hayes
CorrespondentHarry Hayes
BIOLITEC MEDICAL DEVICES, INC 1349 MAIN ROAD Grandville,  MA  01034
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-08-10
Decision Date2011-11-03
Summary:summary

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