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FDA 510(k) Application Details - K120189
Device Classification Name
Instrument, Biopsy
More FDA Info for this Device
510(K) Number
K120189
Device Name
Instrument, Biopsy
Applicant
BERNI FARNS INCORPORATED
P.O. BOX 139
FERNANDINA BEACH, FL 32035 US
Other 510(k) Applications for this Company
Contact
NICOLA BERNI
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
01/23/2012
Decision Date
02/22/2012
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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