FDA 510(k) Applications Submitted by HyunDae MediTech Co., Ltd.

FDA 510(k) Number Submission Date Device Name Applicant
K240389 02/08/2024 Secret Line up (FCL18100C160 FCL19100E160 FCL1990E150 FCL2190G150 ); i-Thread (FCL18100C160 FCL19100E160 FCL1990E150 FCL2190G150) HyunDae MediTech Co., Ltd.
K242571 08/29/2024 Secret Line up (FC1938E80 FC1950E90 FC1960E100 FC1970E120 FC1990E150 FC19100E150 FC19100E280 FC19100E420 FC2038E80 FC2050E90 FC2060E100 FC2070E120 FC2090E150 FC20100E170 FC2138G80 FC2150G90 FC2160G100 FC2170G120 FC2190G150 FC21100G170 FCL18100C160 FCL1938 Hyundae Meditech Co., Ltd.


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