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FDA 510(k) Application Details - K153655
Device Classification Name
Catheter, Retention Type, Balloon
More FDA Info for this Device
510(K) Number
K153655
Device Name
Catheter, Retention Type, Balloon
Applicant
POTRERO MEDICAL, INC.
101 MISSISSIPPI ST.
SAN FRANCISCO, CA 94107 US
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Contact
DEVYANI NANDURI
Other 510(k) Applications for this Contact
Regulation Number
876.5130
More FDA Info for this Regulation Number
Classification Product Code
EZL
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
12/21/2015
Decision Date
04/15/2016
Decision
SESK - SUBST EQUIV - KIT
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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