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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 K250115
Device Name Hemastyl(™) Wound Dressing
Applicant
Rapid Nexus Nanotech Wound Solutions, Inc.
830 Challenger St., Suite 360
Brea,  CA  92821
Applicant Contact Margaret Kalmeta
Correspondent
Schuler Medical Device
5729 Lebanon Rd.
Suite 144616
Frisco,  TX  75034
Correspondent Contact Denise Holliday
Classification Product Code
FRO  
Date Received01/16/2025
Decision Date 10/14/2025
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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