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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 K212579
Device Name FortiShield (Biosynthetic Wound Matrix)
Applicant
Organogenesis, Inc.
150 Dan Rd.
Canton,  MA  02021
Applicant Contact Christina Nichols
Correspondent
Organogenesis, Inc.
150 Dan Rd.
Canton,  MA  02021
Correspondent Contact Christina Nichols
Classification Product Code
KGN  
Date Received08/16/2021
Decision Date 05/02/2023
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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