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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 K210024
Device Name NeoMatriX Wound Matrix
Applicant
Nextgen Biologics, Inc.
13709 Progress Blvd. Box11
Alachua,  FL  32615
Applicant Contact Jonelle L. Toothman
Correspondent
Hogan Lovells Llp
1735 Market St., Suite 2300
Hiladelphia,  PA  19103
Correspondent Contact Janice Hogan
Classification Product Code
KGN  
Date Received01/04/2021
Decision Date 10/07/2021
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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