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FDA 510(k) Application Details - K192908
Device Classification Name
Endoscopic Cytology Brush
More FDA Info for this Device
510(K) Number
K192908
Device Name
Endoscopic Cytology Brush
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
876.1500
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Classification Product Code
FDX
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More FDA Info for this Product Code
Date Received
10/15/2019
Decision Date
11/14/2019
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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