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U.S. Department of Health and Human Services

510(k) Premarket Notification
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510(k) Number K261775
Device Name Uv Phototherapy (KN-4001A,KN-4001B,KN-4001AB)
Applicant
Xuzhou Kernel Medical Equipment Co., Ltd.
Kernel Mansion, Economic Development District
Xuzhou,  CN 221004
Applicant Contact Shanfeng Jiang
Correspondent
Xuzhou Kernel Medical Equipment Co., Ltd.
Kernel Mansion, Economic Development District
Xuzhou,  CN 221004
Correspondent Contact Shanfeng Jiang
Subsequent Product Code
FTC  
Date Received05/29/2026
Decision Date 07/21/2026
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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