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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 K182010
Device Name ProgenaMatrix
Applicant
Cell Constructs I, LLC
7828 Hickory Flat Highway Suite 120
Woodstock,  GA  30188
Applicant Contact Elizabeth O'Keeffe
Correspondent
Secure BioMed Evaluations
7828 Hickory Flat Highway Suite 120
Woodstock,  GA  30188
Correspondent Contact Elizabeth O'Keefe
Classification Product Code
KGN  
Date Received07/27/2018
Decision Date 01/17/2019
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
Recalls CDRH Recalls
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