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FDA 510(k) Application Details - K201322
Device Classification Name
Tubes, Gastrointestinal (And Accessories)
More FDA Info for this Device
510(K) Number
K201322
Device Name
Tubes, Gastrointestinal (And Accessories)
Applicant
Wilson-Cook Medical, Inc
4900 Bethania Station Road
Winston-Salem, NC 27105 US
Other 510(k) Applications for this Company
Contact
Tiffanny A Thomas
Other 510(k) Applications for this Contact
Regulation Number
876.5980
More FDA Info for this Regulation Number
Classification Product Code
KNT
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
05/18/2020
Decision Date
06/17/2020
Decision
SESK - SUBST EQUIV - KIT
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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