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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 K250890
Device Name SBC1 Cream
Applicant
Sioxmed, LLC
2452 Salem Park Dr.
Winston Salem,  NC  27127
Applicant Contact Mitchell Dellinger
Correspondent
Propharma
107 W. Hargett St.
Raleigh,  NC  27601
Correspondent Contact Jennifer Daudelin
Classification Product Code
FRO  
Date Received03/25/2025
Decision Date 01/12/2026
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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