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FDA 510(k) Application Details - K171947
Device Classification Name
System,Surgical,Computer Controlled Instrument
More FDA Info for this Device
510(K) Number
K171947
Device Name
System,Surgical,Computer Controlled Instrument
Applicant
AKTORmed GmbH
Borsigstrabe 13
Barbing 93092 DE
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Contact
Andreas Mohr
Other 510(k) Applications for this Contact
Regulation Number
876.1500
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Classification Product Code
NAY
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More FDA Info for this Product Code
Date Received
06/29/2017
Decision Date
09/21/2018
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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