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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Cord, Retraction
510(k) Number K253797
Device Name One-Stop
Applicant
Mediclus Co., Ltd.
#1210, 134, Gongdan-Ro, Heungdeok-Gu
Cheongju-Si,  KR 28576
Applicant Contact Ku Da Hyeon
Correspondent
Mediclus Co., Ltd.
#1210, 134, Gongdan-Ro, Heungdeok-Gu
Cheongju-Si,  KR 28576
Correspondent Contact Ku Da Hyeon
Classification Product Code
MVL  
Date Received11/28/2025
Decision Date 02/27/2026
Decision Substantially Equivalent (SESE)
510k Review Panel Dental
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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