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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 K190840
Device Name Medtronic Transportation / Sterilization Cassettes
Applicant
Medtronic Sofamor Danek USA, Inc.
1800 Pyramid Place
Memphis,  TN  38132
Applicant Contact Elizabeth Hamilton
Correspondent
Medtronic Sofamor Danek USA, Inc.
1800 Pyramid Place
Memphis,  TN  38132
Correspondent Contact Elizabeth Hamilton
Regulation Number880.6850
Classification Product Code
KCT  
Date Received04/01/2019
Decision Date 10/15/2019
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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