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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Dressing, Wound, Drug
510(k) Number K252023
Device Name MiraChlor Antimicrobial Wound Solution
Applicant
Letus Corporation
9404 SE Sun Crest Dr.
Happy Valley,  OR  97086
Applicant Contact Gia-Thanh Tu Le
Correspondent
Mcra, LLC
803 7th St. NW, 4th Floor
Washington,  DC  20001
Correspondent Contact Mehdi Kazemzadeh-Narbat
Classification Product Code
FRO  
Date Received06/30/2025
Decision Date 03/25/2026
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product Yes
Predetermined Change
Control Plan Authorized		 No
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