Quick Links: Skip to main page content Skip to Search Skip to Topics Menu Skip to Common Links
  • Decrease font size
  • Return font size to normal
  • Increase font size
U.S. Department of Health and Human Services

510(k) Premarket Notification
  • Print
  • Share
  • E-mail
-
Super Search Devices@FDA
510(k) | DeNovo | Registration & Listing | Adverse Events | Recalls | PMA | HDE | Classification | Standards
CFR Title 21 | Radiation-Emitting Products | X-Ray Assembler | Medsun Reports | CLIA | TPLC
 


New Search Back To Search Results
Device Classification Name Dressing, Wound, Drug
510(k) Number K242406
Device Name SiOxC Cream
Applicant
Sioxmed, LLC
2011 Muddy Creek Rd.
Clemmons,  NC  27012
Applicant Contact Adam Jorgensen
Correspondent
Sioxmed, LLC
2542 Salem Park Dr.
Winston-Salem,  NC  27127
Correspondent Contact Adam Jorgensen
Classification Product Code
FRO  
Date Received08/14/2024
Decision Date 03/13/2025
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
-
-