Ultravision Visual Field Clearing System

Surgical Smoke Precipitator

Alesi Surgical Ltd.

The following data is part of a premarket notification filed by Alesi Surgical Ltd. with the FDA for Ultravision Visual Field Clearing System.

Pre-market Notification Details

Device IDK170178
510k NumberK170178
Device Name:Ultravision Visual Field Clearing System
ClassificationSurgical Smoke Precipitator
Applicant Alesi Surgical Ltd. Cardiff MediCentre, Heath Park Cardiff,  GB Cf14 4uj
ContactDavid Broderick
CorrespondentDavid Broderick
Alesi Surgical Ltd. Cardiff MediCentre, Heath Park Cardiff,  GB Cf14 4uj
Product CodePQM  
CFR Regulation Number878.5050 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-01-19
Decision Date2017-05-26
Summary:summary

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