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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 ingestible event marker
De Novo Number DEN120011
510(K) Number K113070
Device Name PROTEUS INGESTION CONFINMATION SYSTEMS
Requester
PROTEUS BIOMEDICAL, INC.
2600 bridge parkway
suite 101
redwood city,  CA  94065
Contact jafar shenasa
Regulation Number880.6305
Classification Product Code
OZW  
Date Received05/11/2012
Decision Date 07/10/2012
Decision granted (DENG)
Classification Advisory Committee General Hospital
Review Advisory Committee Gastroenterology/Urology
Reclassification Order Reclassification Order
FDA Review Decision Summary
Type Post-NSE
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