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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 K241904
Device Name DermiSphere Dermal Template
Applicant
Fesariustherapeutics, Inc.
760 Parkside Ave., Suite 218
Brooklyn,  NY  11226
Applicant Contact Yulia Sapir-Lekhovitser
Correspondent
Regenity Biosciences
115 W. Century Rd. Suite 380
Paramus,  NJ  07652
Correspondent Contact Diana Bordon
Classification Product Code
KGN  
Subsequent Product Code
FTM  
Date Received07/01/2024
Decision Date 01/06/2025
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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