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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Arthroscope
510(k) Number K171237
Device Name FMS VUE II Fluid Management and Tissue Debridement System
Applicant
Medos International SARL
Chemin-Blanc 38
Lelocle,  CH 2400
Applicant Contact Tatyana Korsunsky
Correspondent
Depuy Mitek, A Johnson and Johnson Company
325 Paramount Dr.
Raynham,  MA  02767
Correspondent Contact Tatyana Korsunsky
Regulation Number888.1100
Classification Product Code
HRX  
Date Received04/27/2017
Decision Date 01/18/2018
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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