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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, Drug
510(k) Number K192478
Device Name LT Antibacterial Alginate with Silver Dressing
Applicant
Zhejiang Longterm Medical Technology Co., Ltd.
No. 493 North Huancheng Road, Mogan Mountain National High-
Tech District
Deqing,  CN 313200
Applicant Contact Claudia Zsang
Correspondent
Zhenjiang Longterm Medical Technology Co., Ltd.
No. 493 North Huancheng Road, Morgan Mountain National High-
Tech District
Deqing,  CN 313200
Correspondent Contact Claudia Zsang
Classification Product Code
FRO  
Date Received09/10/2019
Decision Date 06/17/2020
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
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