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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wound Dressing With Animal-Derived Material(S)
510(k) Number K253974
Device Name Roosin Collagen Dressing
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
KGN  
Date Received12/11/2025
Decision Date 06/03/2026
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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