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FDA 510(k) Application Details - K172602
Device Classification Name
Suture, Surgical, Absorbable, Polydioxanone
More FDA Info for this Device
510(K) Number
K172602
Device Name
Suture, Surgical, Absorbable, Polydioxanone
Applicant
Feeltech Co., Ltd.
3,4 Floor Standard Factory 2-dong, 15 Jayumuyeok 2-gil
Gunsan-si 573-540 KR
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Contact
Keun-Sik Kim
Other 510(k) Applications for this Contact
Regulation Number
878.4840
More FDA Info for this Regulation Number
Classification Product Code
NEW
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/30/2017
Decision Date
11/14/2018
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
SU - General & Plastic Surgery
Review Advisory Committee
SU - General & Plastic Surgery
Statement / Summary / Purged Status
Summary
Type
Traditional
Reviewed By Third Party
N
Expedited Review
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