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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 K254239
Device Name CyClean Cord
Applicant
SS GLOBAL
101-#304, Chunui-Technopark, 36, Bucheon-Ro 198 Beon-Gil
Bucheon-Si,  KR 14557
Applicant Contact Jun Hwan Ahn
Correspondent
LK Consulting Group USA, Inc.
2552 Walnut Ave. Suite 230
Tustin,  CA  92780
Correspondent Contact Priscilla Chung
Classification Product Code
MVL  
Date Received12/29/2025
Decision Date 03/27/2026
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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