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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 K260669
Device Name Endoform Dermal Template
Applicant
Aroa Biosurgery , Ltd.
2 Kingsford Smith Pl.
Airport Oaks
Auckland,  NZ 2022
Applicant Contact Thanh Minh Lam
Correspondent
Aroa Biosurgery , Ltd.
2 Kingsford Smith Pl.
Airport Oaks
Auckland,  NZ 2022
Correspondent Contact Thanh Minh Lam
Classification Product Code
KGN  
Date Received03/02/2026
Decision Date 06/24/2026
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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