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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Surgical Smoke Precipitator
510(k) Number K231238
Device Name Ultravision2™ System
Applicant
Alesi Surgical Ltd
128 Blye Hill Landing
Newbury,  NH  03255
Applicant Contact Michele Lucey
Correspondent
Lakeshore Medical Device Consulting, LLC
128 Blye Hill Landing
Newbury,  NH  03255
Correspondent Contact Michele Lucey
Regulation Number878.5050
Classification Product Code
PQM  
Date Received04/28/2023
Decision Date 10/31/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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