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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Sterilization Wrap Containers, Trays, Cassettes & Other Accessories
510(k) Number K201412
Device Name BEGO SEMADOS Tr 58350; BEGO SEMADOS RS/RSX-Line Tray Plus, BEGO Semados Tr 58349; BEGO Semados Tr 58348, BEGO Semados DSTr 58356; Drill Stop Tray Plus (RS/RSX-Line), BEGO SEMADOS PKTr 58357; Prosthetic Kit
Applicant
Bego Implant Systems GmbH & Co. KG
Wilhelm-Herbst-Str. 1
Bremen,  DE 28359
Applicant Contact Bertrand Lecointe
Correspondent
Bego Implant Systems GmbH & Co. KG
Wilhelm-Herbst-Str. 1
Bremen,  DE 28359
Correspondent Contact Bertrand Lecointe
Regulation Number880.6850
Classification Product Code
KCT  
Date Received05/28/2020
Decision Date 02/18/2021
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
510k Review Panel General Hospital
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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