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FDA 510(k) Application Details - K173108
Device Classification Name
Apparatus, Exhaust, Surgical
More FDA Info for this Device
510(K) Number
K173108
Device Name
Apparatus, Exhaust, Surgical
Applicant
Sejong Medical Co., Ltd.
11, Sinchon 2-ro
Paju-si 10880 KR
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Contact
Yoojung Choi
Other 510(k) Applications for this Contact
Regulation Number
878.5070
More FDA Info for this Regulation Number
Classification Product Code
FYD
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
09/29/2017
Decision Date
05/18/2018
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
HO - General Hospital
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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