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FDA 510(k) Application Details - K162588
Device Classification Name
Instrument, Biopsy
More FDA Info for this Device
510(K) Number
K162588
Device Name
Instrument, Biopsy
Applicant
Moller Medical GmbH
Wasserkuppenstrabe 29-31
Fulda 36043 DE
Other 510(k) Applications for this Company
Contact
Christoph Traxler
Other 510(k) Applications for this Contact
Regulation Number
876.1075
More FDA Info for this Regulation Number
Classification Product Code
KNW
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More FDA Info for this Product Code
Date Received
09/16/2016
Decision Date
06/19/2017
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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