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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 K170178
Device Name Ultravision Visual Field Clearing System
Applicant
Alesi Surgical, Ltd.
Cardiff Medicentre, Heath Park
Cardiff,  GB CF14 4UJ
Applicant Contact DAVID BRODERICK
Correspondent
Alesi Surgical, Ltd.
Cardiff Medicentre, Heath Park
Cardiff,  GB CF14 4UJ
Correspondent Contact DAVID BRODERICK
Regulation Number878.5050
Classification Product Code
PQM  
Date Received01/19/2017
Decision Date 05/26/2017
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
Predetermined Change
Control Plan Authorized		 No
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