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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 K221570
Device Name Antibacterial bandage
Applicant
Allmed Medical Products Co., Ltd.
# 99, Jin Shan Rd., Majiadian Town
Zhijiang,  CN 430000
Applicant Contact Vince Tian
Correspondent
Shanghai Sungo Management Consulting Company Limited.
14th Floor, 1500# Central Ave.
Shanghai,  CN 200122
Correspondent Contact Ivy Wang
Classification Product Code
FRO  
Date Received05/31/2022
Decision Date 09/29/2023
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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