FDA.reportPublic FDA data

510(k) K253797

Device
One-Stop
Applicant
Mediclus Co., Ltd.
510(k) number
K253797
Product code
MVL
Decision
Substantially Equivalent (SESE)
Decision date
2026-02-27
Date received
2025-11-28
Classification name
Cord, Retraction
Medical specialty
Unknown
Review panel
Unknown
Device class
U
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Applicant Contact#

Contact
Ku Da Hyeon
Address
# 1210, 134, Gongdan-Ro, Heungdeok-Gu Cheongju-Si KR 28576 28576

FDA Registration Numbers#

Source Documents#

510(k) summary PDF

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K152064Astringedent ClearUltradent Products, Inc.2015-09-24
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