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FDA 510(k) Application Details - K120126
Device Classification Name
Endoscopic Access Overtube, Gastroenterology-Urology
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510(K) Number
K120126
Device Name
Endoscopic Access Overtube, Gastroenterology-Urology
Applicant
BAROSENSE, INC
250 CHESAPEAKE DRIVE
REDWOOD CITY, CA 94063 US
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Contact
SHELIA STEVENS, PHD
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Regulation Number
876.1500
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Classification Product Code
FED
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More FDA Info for this Product Code
Date Received
01/17/2012
Decision Date
09/10/2012
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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