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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
510(k) Number K192452
Device Name Lyograft
Applicant
B. Bruan Surgical, SA
Carretera Terrassa 121
Rubi,  ES 08191
Applicant Contact Pau Turon Dols
Correspondent
Qreg Consulting, LLC
2192 Martin Drive
Gilbertsville,  PA  19525
Correspondent Contact Robin M Fatzinger
Regulation Number878.3300
Classification Product Code
FTM  
Date Received09/09/2019
Decision Date 09/03/2020
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
Predetermined Change
Control Plan Authorized		 No
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