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FDA 510(k) Applications Submitted by Gemss Healthcare Co., Ltd.
FDA 510(k) Number
Submission Date
Device Name
Applicant
K230800
03/23/2023
XVISION-525, HORIZON, HI-300, HI-500, SATURN-F PF32, SATURN-F PF40, SATURN-F PF50
Gemss Healthcare Co., Ltd.
K233200
09/28/2023
XPLUS 35 Series (XPLUS 35, XPLUS 35FD)
Gemss Healthcare Co., Ltd.
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