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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 K201324
Device Name Antibacterial Bandage
Applicant
Jiangsu Excellence Medical Supplies Co., Ltd.
#65 Huiling W. Rd., Zouqu Town, Zhonglou District
Changzhou,  CN 203144
Applicant Contact Yanhua Li
Correspondent
Mid-Link Consulting Co, Ltd.
P.O. Box 120-119
Shanghai,  CN 200120
Correspondent Contact Diana Hong
Classification Product Code
FRO  
Date Received05/18/2020
Decision Date 02/05/2021
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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