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FDA 510(k) Application Details - K131655
Device Classification Name
Catheter, Retention Type, Balloon
More FDA Info for this Device
510(K) Number
K131655
Device Name
Catheter, Retention Type, Balloon
Applicant
SEEDINGS LIFE SCIENCE VENTURES, LLC
230 EAST 15TH STREET
SUITE 1-A
NEW YORK, NY 10003 US
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Contact
KEN SOLOVAY
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
06/06/2013
Decision Date
11/04/2013
Decision
SESE - SUBST EQUIV
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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