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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 K192636
Device Name TYRX Neuro Absorbable Antibacterial Envelope (Medium), TYRX Neuro Absorbable Antibacterial Envelope (Large)
Applicant
Medtronic, Inc.
8200 Coral Sea St NE
Mounds View,  MN  55112
Applicant Contact Nancy Cameron
Correspondent
Medtronic, Inc.
8200 Coral Sea St NE
Mounds View,  MN  55112
Correspondent Contact Nancy Cameron
Regulation Number878.3300
Classification Product Code
FTL  
Date Received09/23/2019
Decision Date 04/08/2020
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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