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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 K260652
Device Name ColActive Plus
Applicant
Covalon Technologies, Ltd.
1660 Tech Ave.
Unit 5
Mississauga,  CA L4W 5S7
Applicant Contact Christina Mitchell
Correspondent
Covalon Technologies, Ltd.
1660 Tech Ave.
Unit 5
Mississauga,  CA L4W 5S7
Correspondent Contact Christina Mitchell
Classification Product Code
KGN  
Date Received02/27/2026
Decision Date 09/09/2026
Decision Substantially Equivalent (SESE)
510k Review Panel General & Plastic Surgery
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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