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FDA 510(k) Application Details - K131950
Device Classification Name
Needle, Fistula
More FDA Info for this Device
510(K) Number
K131950
Device Name
Needle, Fistula
Applicant
SUMMIT INTERNATIONAL MEDICAL TECHNOLOGIES, INC.
7 MEADOW WOOD ROAD
KINGSTON, NH 03848 US
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Contact
RICHELLE HELMAN
Other 510(k) Applications for this Contact
Regulation Number
876.5540
More FDA Info for this Regulation Number
Classification Product Code
FIE
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
06/27/2013
Decision Date
01/16/2015
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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