DEKA SMARTXIDE AND DELIVERY ACCESSORIES

Powered Laser Surgical Instrument

EL.EN. ELECTRONIC ENGINEERING SPA

The following data is part of a premarket notification filed by El.en. Electronic Engineering Spa with the FDA for Deka Smartxide And Delivery Accessories.

Pre-market Notification Details

Device IDK113504
510k NumberK113504
Device Name:DEKA SMARTXIDE AND DELIVERY ACCESSORIES
ClassificationPowered Laser Surgical Instrument
Applicant EL.EN. ELECTRONIC ENGINEERING SPA 17 VIA BALDANZESE Calenzano,  IT 50041
ContactPaolo Peruzzi
CorrespondentPaolo Peruzzi
EL.EN. ELECTRONIC ENGINEERING SPA 17 VIA BALDANZESE Calenzano,  IT 50041
Product CodeGEX  
CFR Regulation Number878.4810 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2011-11-28
Decision Date2013-02-01
Summary:summary

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