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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 K180894
Device Name Magnetic Surgical System
Applicant
Levita Magnetics International Corp
1730 S.Amphlett Blvd., Suite 240
San Mateo,  CA  94402
Applicant Contact Alberto Rodrigues-Navarro
Correspondent
Domecus Consulting Services, LLC
1171 Barroilhet Dr.
Hillsborough,  CA  94010
Correspondent Contact Cindy Domecus
Regulation Number878.4815
Classification Product Code
PNL  
Date Received04/05/2018
Decision Date 09/19/2018
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
Predetermined Change
Control Plan Authorized		 No
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