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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 K252435
Device Name Magnetic Surgical System
Applicant
Levita Magnetics International Corp
453 Ravendale Dr.
Mountain View,  CA  94063
Applicant Contact Donielle Baudin
Correspondent
Domecus Consulting Services
1171 Barroihet Dr.
Hillsborough,  CA  94070
Correspondent Contact Cindy Domecus
Regulation Number878.4815
Classification Product Code
PNL  
Date Received08/01/2025
Decision Date 09/26/2025
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Clinical Trials NCT02049983
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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