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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name mesh, surgical, polymeric
510(k) Number K191545
Device Name Exogenesis Hernia Mesh
Applicant
Exogenesis Corporation
20 Fortune Drive
Billerica,  MA  01821
Applicant Contact Joseph Khoury
Correspondent
O'Connell Regulatory Consultants, Inc.
44 Oak Street
Stoneham,  MA  02180
Correspondent Contact Maureen O'Connell
Regulation Number878.3300
Classification Product Code
FTL  
Date Received06/11/2019
Decision Date 09/26/2019
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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