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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 K251582
Device Name Redermax Antibacterial Wound Matrix
Applicant
Beijing Kreate Medical Co., Ltd.
C306, W. Ring S. Rd. #18, E-Town
Beijing,  CN 100023
Applicant Contact Sean Chen
Correspondent
Scientific Horizons Consulting, LLC
5270 California Ave.
Suite 300
Irvine,  CA  92617
Correspondent Contact Christopher Swanson
Classification Product Code
FRO  
Date Received05/23/2025
Decision Date 02/02/2026
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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