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FDA 510(k) Application Details - K153550
Device Classification Name
More FDA Info for this Device
510(K) Number
K153550
Device Name
FTRD System Set
Applicant
OVESCO ENDOSCOPY AG
DORFACKERSTRASSE 26
TUEBINGEN 72074 DE
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Contact
MARC O. SCHURR
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Regulation Number
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Classification Product Code
PKL
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Date Received
12/11/2015
Decision Date
10/12/2016
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Statement
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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