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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 K231088
Device Name Copper Foam Dressing (Prescription and OTC)
Applicant
Roosin Medical Co., Ltd.
#8 Yuandong Rd., Kouan Town,
Gaogang
Taizhou,  CN 225321
Applicant Contact Dayong Chen
Correspondent
Manton Business and Technology Services
37 Winding Ridge
Oakland,  NJ  07436
Correspondent Contact Charles Shen
Classification Product Code
FRO  
Date Received04/17/2023
Decision Date 01/11/2024
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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