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FDA 510(k) Application Details - K223067
Device Classification Name
Stent,Metallic,Expandable,Duodenal
More FDA Info for this Device
510(K) Number
K223067
Device Name
Stent,Metallic,Expandable,Duodenal
Applicant
Taewoong Medical Co., Ltd.
14 Gojeong-ro, Wolgot-myeon
Gimpo-si 10022 KR
Other 510(k) Applications for this Company
Contact
Yongjin Kim
Other 510(k) Applications for this Contact
Regulation Number
878.3610
More FDA Info for this Regulation Number
Classification Product Code
MUM
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/23/2022
Decision Date
06/14/2023
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
GU - Gastroenterology & Urology
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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