K240389

Secret Line up (FCL18100C160 FCL19100E160 FCL1990E150 FCL2190G150 ); i-Thread (FCL18100C160 FCL19100E160 FCL1990E150 FCL2190G150)

510(k) number: K240389
Device name: Secret Line up (FCL18100C160 FCL19100E160 FCL1990E150 FCL2190G150 ); i-Thread (FCL18100C160 FCL19100E160 FCL1990E150 FCL2190G150)
Applicant: Hyundae Meditech Co., Ltd. KR
Product code: NEW — Suture, Surgical, Absorbable, Polydioxanone
Decision date: 2024-03-27
Date received: 2024-02-08
Decision: Substantially Equivalent
Clearance type: Traditional
Advisory committee: General, Plastic Surgery

510(k) Summary (official FDA PDF): K240389.pdf

Official FDA record: K240389

Data from the openFDA 510(k) dataset (CC0). A 510(k) clearance is not an FDA approval or certification.