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FDA 510(k) Application Details - K142688
Device Classification Name
Kit, Needle, Biopsy
More FDA Info for this Device
510(K) Number
K142688
Device Name
Kit, Needle, Biopsy
Applicant
COOK IRELAND LTD
O'HALLORAN ROAD
NATIONAL TECHNOLOGY PARK
LIMERICK IE
Other 510(k) Applications for this Company
Contact
Nora O'Connor
Other 510(k) Applications for this Contact
Regulation Number
876.1075
More FDA Info for this Regulation Number
Classification Product Code
FCG
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/22/2014
Decision Date
12/19/2014
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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