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U.S. Department of Health and Human Services

Device Classification Under Section 513(f)(2)(De Novo)
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Device Classification Name magnetic surgical system
De Novo Number DEN150007
Device Name Magnetic Surgical System
Requester
levita magnetics international corp.
1730 s.amphlett blvd, ste 220
san mateo,  CA  94402
Contact cindy domecus
Regulation Number878.4815
Classification Product Code
PNL  
Date Received02/10/2015
Decision Date 06/13/2016
Decision granted (DENG)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
Classification Order Classification Order
FDA Review Decision Summary
Type Direct
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