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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Absorbable Synthetic Wound Dressing
510(k) Number K260020
Device Name Redermo Wound Matrix
Applicant
Beijing Kreate Medical Co., Ltd.
C306, W. Ring S. Rd. #18, E-Town
Beijing,  CN 100023
Applicant Contact Gary Gao
Correspondent
Scientific Horizons Consulting, LLC
5270 California Ave.
Suite 300
Irvine,  CA  92617
Correspondent Contact Christopher Swanson
Classification Product Code
QSZ  
Date Received01/05/2026
Decision Date 04/16/2026
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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