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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wound Dressing With Animal-Derived Material(S)
510(k) Number K253339
Device Name Theracor
Applicant
Stimlabs, LLC
1225 Northmeadow Pkwy.
Suite 104
Roswell,  GA  30076
Applicant Contact Melissa O'Connor
Correspondent
Stimlabs, LLC
1225 Northmeadow Pkwy.
Suite 104
Roswell,  GA  30076
Correspondent Contact Melissa O'Connor
Classification Product Code
KGN  
Date Received09/30/2025
Decision Date 12/22/2025
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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