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FDA 510(k) Application Details - K213483
Device Classification Name
Endoscope Channel Accessory
More FDA Info for this Device
510(K) Number
K213483
Device Name
Endoscope Channel Accessory
Applicant
Wilson Cook Medical
4900 Bethania Station Road
Winston-Salem, NC 27105 US
Other 510(k) Applications for this Company
Contact
Paul Meyer
Other 510(k) Applications for this Contact
Regulation Number
876.1500
More FDA Info for this Regulation Number
Classification Product Code
ODC
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More FDA Info for this Product Code
Date Received
10/29/2021
Decision Date
04/26/2022
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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