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FDA 510(k) Application Details - K172288
Device Classification Name
Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
More FDA Info for this Device
510(K) Number
K172288
Device Name
Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Applicant
Wilson-Cook Medical, Inc./ Cook Endoscopy
4900 Bethania Station Road
Winston Salem, NC 27105 US
Other 510(k) Applications for this Company
Contact
Sierra Lowe
Other 510(k) Applications for this Contact
Regulation Number
876.4300
More FDA Info for this Regulation Number
Classification Product Code
KNS
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
07/31/2017
Decision Date
04/17/2018
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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