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510(k) K240389

Secret Line up (FCL18100C160 FCL19100E160 FCL1990E150 FCL2190G150 ); i-Thread (FCL18100C160 FCL19100E160 FCL1990E150 FCL2190G150) by Hyundae Meditech Co., Ltd. — Product Code NEW

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 27, 2024
Date Received
February 8, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Suture, Surgical, Absorbable, Polydioxanone
Device Class
Class II
Regulation Number
878.4840
Review Panel
SU
Submission Type

Other clearances by Hyundae Meditech Co., Ltd.

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