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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name powered laser surgical instrument
510(k) Number K191962
Device Name Vitra 2
Applicant
Quantel Medical
11 Rue du Bois Joli-CS40015
Cournon D'Auvergne-Cedex,  FR 63808
Applicant Contact Bruno Pages
Correspondent
O'Connell Regulatory Consultants, Inc.
44 Oak Street
Stoneham,  MA  02180
Correspondent Contact Maureen O'Connell
Regulation Number878.4810
Classification Product Code
GEX  
Date Received07/23/2019
Decision Date 12/05/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel Ophthalmic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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