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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 K260218
Device Name LacertaMatrix
Applicant
Lacerta Life Sciences
7842 Hickory Flat Hwy.
Woodstock,  GA  30188
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 Received01/23/2026
Decision Date 02/19/2026
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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