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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 K201113
Device Name Resascope RS-01/B
Applicant
Advanced Medical Systems Group SRL
Via Europa 12
San Pietro Viminario,  IT 35020
Applicant Contact Francesco Sgarbi
Correspondent
Advanced Medical Systems Group SRL
Via Europa 12
San Pietro Viminario,  IT 35020
Correspondent Contact Francesco Sgarbi
Regulation Number888.1100
Classification Product Code
HRX  
Date Received04/27/2020
Decision Date 12/21/2020
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Orthopedic
510k Review Panel Orthopedic
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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