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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 K243166
Device Name Dermalage
Applicant
Infection Elimination Solutions, LLC
1142 Grove Rd.
Greenville,  SC  29605
Applicant Contact Patrick Hill
Correspondent
ProPharma MedTech
1129 20th St. NW, Suite 600
Washington,  DC  20036
Correspondent Contact Connie Qiu
Classification Product Code
FRO  
Date Received09/30/2024
Decision Date 08/27/2025
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
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