FDA.report

510(k) K252023

Device
MiraChlor Antimicrobial Wound Solution
Applicant
Letus Corporation
510(k) number
K252023
Product code
FRO
Decision
Substantially Equivalent (SESE)
Decision date
2026-03-25
Date received
2025-06-30
Classification name
Dressing, Wound, Drug
Medical specialty
Unknown
Review panel
Unknown
Device class
U
Clearance type
Traditional
Statement or summary
Summary
Third party reviewed
N

Related Records

Applicant Contact

Contact
Gia-Thanh Tu Le
Address
9404 SE Sun Crest Dr. Happy Valley OR US 97086 97086

FDA Registration Numbers

Source Documents

510(k) summary PDF

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