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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name Powered Light Based Non-Laser Surgical Instrument With Thermal Effect
510(k) Number K090399
Device Name TRIOS SYSTEM
Applicant
VIORA LTD.
30 MONTGOMERY STREET
SUITE 660
JERSEY CITY,  NJ  07302
Applicant Contact JOSEF LUZON
Correspondent
VIORA LTD.
30 MONTGOMERY STREET
SUITE 660
JERSEY CITY,  NJ  07302
Correspondent Contact JOSEF LUZON
Regulation Number878.4810
Classification Product Code
ONF  
Date Received02/17/2009
Decision Date 06/10/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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