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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 K222189
Device Name SiOxD Wound Matrix
Applicant
Sioxmed, LLC
2011 Muddy Creek Rd.
Clemmons,  NC  27012
Applicant Contact Mitch Dellinger
Correspondent
Secure Biomed Evalutations
7828 Hickory Flat Hwy., Suite 120
Woodstock,  GA  30188
Correspondent Contact Linda Braddon
Classification Product Code
QSZ  
Date Received07/22/2022
Decision Date 11/18/2022
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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