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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 K252673
Device Name LacertaMatrix
Applicant
Lacerta Life Science
1169 Wall Rd.
Broussard,  LA  70518
Applicant Contact Ted Bundrick
Correspondent
Secure BioMed Evaluations
7828 Hickory Flat Hwy Suite 120
Woodstock,  GA  30188
Correspondent Contact Justin Gracyalny
Classification Product Code
KGN  
Date Received08/25/2025
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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