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FDA 510(k) Application Details - K171596
Device Classification Name
Kit, Needle, Biopsy
More FDA Info for this Device
510(K) Number
K171596
Device Name
Kit, Needle, Biopsy
Applicant
Wilson-Cook Medical Inc.
4900 Bethania Station Road
Winston-Salem, NC 27105 US
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Contact
Tiffanny A. Thomas
Other 510(k) Applications for this Contact
Regulation Number
876.1075
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Classification Product Code
FCG
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More FDA Info for this Product Code
Date Received
05/31/2017
Decision Date
08/04/2017
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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