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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 K243317
Device Name NUVENTUS NV.C™ Surgical Cassette and Tray
Applicant
Infinitum Eta, Ltd.
Hatnufa St. 6
Petach Tikva,  IL 4951024
Applicant Contact Avital Barlev
Correspondent
Infinitum Eta, Ltd.
Hatnufa St. 6
Petach Tikva,  IL 4951024
Correspondent Contact Avital Barlev
Regulation Number880.6850
Classification Product Code
KCT  
Date Received10/22/2024
Decision Date 02/11/2025
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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