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FDA 510(k) Application Details - K192101
Device Classification Name
Instrument, Biopsy
More FDA Info for this Device
510(K) Number
K192101
Device Name
Instrument, Biopsy
Applicant
Medax Srl Unipersonale
Via R.Piva, 1/A
Poggio Rusco 46025 IT
Other 510(k) Applications for this Company
Contact
Stefano Cavalieri
Other 510(k) Applications for this Contact
Regulation Number
876.1075
More FDA Info for this Regulation Number
Classification Product Code
KNW
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/05/2019
Decision Date
04/02/2020
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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