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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dressing, Wound, Occlusive
510(k) Number K254246
Device Name LT Antibacterial Foam with Silver Dressing
Applicant
Zhejiang Longterm Medical Technology Co., Ltd.
Shuangshan Rd. 277, Fuxi St.
Deqing,  CN 313200
Applicant Contact Claudia Zsang
Correspondent
Zhejiang Longterm Medical Technology Co., Ltd.
Shuangshan Rd. 277, Fuxi St.
Deqing,  CN 313200
Correspondent Contact Claudia Zsang
Regulation Number878.4020
Classification Product Code
NAD  
Subsequent Product Code
FRO  
Date Received12/29/2025
Decision Date 09/10/2026
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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