FDA 510(k) Application Details - DEN120011

Device Classification Name

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510(K) Number DEN120011
Device Name PROTEUS INGESTION CONFINMATION SYSTEMS
Applicant PROTEUS BIOMEDICAL, INC.
2600 BRIDGE PARKWAY
SUITE 101
REDWOOD CITY, CA 94065 US
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Contact JAFAR SHENASA
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Regulation Number

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Classification Product Code OZW
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Date Received 05/11/2012
Decision Date 07/10/2012
Decision DENG -
Classification Advisory Committee HO - General Hospital
Review Advisory Committee GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Type Post-NSE
Reviewed By Third Party N
Expedited Review



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