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작성자 최고관리자 댓글 0건 조회 1,733회 작성일 20-06-17 17:11

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The Center for Devices and Radiological Health (CDRH) of the Food and Drug Administration (FDA) has received your submission. This submission has been assigned the unique document control number below. All future correspondence regarding this submission should be identified prominently with the number assigned and should be submitted to the Document Control Center at the above letterhead address. Failure to do so may result in processing delays. If you believe the information identified below is incorrect, please notify the Program Operations Staff at (301) 796-5640.

ㆍSubmission Number: K191655/S001

ㆍReceived: 2/5/2020

ㆍApplicant: SeohanCare Co., Ltd

ㆍDevice: MEGAFIX Pedicle Screw Spinal System 

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