FDA 510(k) Application Details - K241660

Device Classification Name Dressing, Wound, Drug

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510(K) Number K241660
Device Name Dressing, Wound, Drug
Applicant SiOxMed, LLC
2011 Muddy Creek Road
Clemmons, NC 27012 US
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Contact Adam Jorgensen
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Regulation Number 000.0000

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Classification Product Code FRO
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Date Received 06/10/2024
Decision Date 07/05/2024
Decision SESE - SUBST EQUIV
Classification Advisory Committee -
Review Advisory Committee SU - General & Plastic Surgery
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review

FDA Source Information for K241660


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