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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 K220498
Device Name NovoGen Wound Matrix
Applicant
Novabone Products, LLC
13510 NW Us Hwy. 441
Alachua,  FL  32615
Applicant Contact Ed Horton
Correspondent
Secure BioMed Evaluations
7828 Hickory Flat Hwy., Suite 120
Woodstock,  GA  30188
Correspondent Contact Linda Braddon
Classification Product Code
KGN  
Date Received02/22/2022
Decision Date 06/09/2023
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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