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FDA 510(k) Application Details - DEN120011
Device Classification Name
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
OZW
Other 510(k) Applications for this Device
More FDA Info for this Product Code
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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