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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 compression anastomosis system
De Novo Number DEN240013
Device Name MagDI System
Requester
gt metabolic solutions, inc.
3050 three springs court
san jose,  CA  95140
Contact lisa griffin vincent
Regulation Number878.4816
Classification Product Code
SAH  
Date Received03/26/2024
Decision Date 07/02/2024
Decision granted (DENG)
Classification Advisory Committee General & Plastic Surgery
Review Advisory Committee General & Plastic Surgery
Classification Order Classification Order
FDA Review Decision Summary
Type Post-NSE
Predetermined Change
Control Plan Authorized		 No
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