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FDA 510(k) Application Details - K111100
Device Classification Name
Instrument, Biopsy
More FDA Info for this Device
510(K) Number
K111100
Device Name
Instrument, Biopsy
Applicant
C.R. BARD, INC.
1415 WEST 3RD ST.
TEMPE, AZ 85281-1740 US
Other 510(k) Applications for this Company
Contact
JUSTIN LOVELACE
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
04/20/2011
Decision Date
06/16/2011
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
GU - Gastroenterology & Urology
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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