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510(k) K242406

SiOxC Cream by Sioxmed, LLC — Product Code FRO

Clearance Details

Decision
SESE (Substantially Equivalent)
Decision Date
March 13, 2025
Date Received
August 14, 2024
Clearance Type
Traditional
Expedited Review
No
Third Party Review
No

Device Classification

Device Name
Dressing, Wound, Drug
Device Class
Class U
Regulation Number
Review Panel
SU
Submission Type

Other clearances by Sioxmed, LLC

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  • K241660 — SiOxD® Wound Matrix (July 5, 2024)
  • K232847 — SiOxD Wound Matrix (December 18, 2023)
  • K222189 — SiOxD Wound Matrix (November 18, 2022)

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