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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 K193608
Device Name EBERLE Shaver System C3 and Accessories
Applicant
Eberle GmbH & Co. KG
Glassbronnenstrasse 6
Wurmberg,  DE 75449
Applicant Contact Udo Schniebs
Correspondent
Visamed GmbH
Kastellstr.8
Karlsruhe,  DE 76227
Correspondent Contact Arne Briest
Regulation Number888.1100
Classification Product Code
HRX  
Date Received12/26/2019
Decision Date 01/15/2021
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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