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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name magnetic surgical system
510(k) Number K223673
Device Name Surgeon Controlled Arm
Levita Magnetics International Corp.
4055-A Campbell Avenue
Menlo Park,  CA  94025
Applicant Contact Alberto Rodriguez-Navarro, MD
Domecus Consulting Services LLC
1171 Barroilhet Drive
Hillsboroguh,  CA  94010
Correspondent Contact Cindy Domecus, RAC (US & EU)
Regulation Number878.4815
Classification Product Code
Date Received12/07/2022
Decision Date 08/04/2023
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No