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FDA 510(k) Application Details - K200404
Device Classification Name
Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
More FDA Info for this Device
510(K) Number
K200404
Device Name
Unit, Electrosurgical, Endoscopic (With Or Without Accessories)
Applicant
Boston Scientific Corporation
300 Boston Scientific Way
Marlborough, MA 01752 US
Other 510(k) Applications for this Company
Contact
Jennifer Edouard
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
02/19/2020
Decision Date
12/03/2020
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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