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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 K191566
Device Name Avinent Surgical Tray
Applicant
Avinent Implant System S.L.U.
Pol. Ind. Santa Anna
Santpedor,  ES 08251
Applicant Contact Anna Cortina
Correspondent
Blackwell Device Consulting
P.O. Box 718
Gresham,  OR  97030
Correspondent Contact Angela Blackwell
Regulation Number880.6850
Classification Product Code
KCT  
Date Received06/13/2019
Decision Date 03/06/2020
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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