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FDA 510(k) Application Details - DEN170015
Device Classification Name
More FDA Info for this Device
510(K) Number
DEN170015
Device Name
Hemospray Endoscopic Hemostat
Applicant
Wilson-Cook Medical, Inc
4900 Bethania Station Road
Winston-Salem, NC 27105 US
Other 510(k) Applications for this Company
Contact
Marge Walls-Walker
Other 510(k) Applications for this Contact
Regulation Number
More FDA Info for this Regulation Number
Classification Product Code
QAU
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
03/09/2017
Decision Date
05/07/2018
Decision
DENG -
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Type
Direct
Reviewed By Third Party
N
Expedited Review
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