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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 K180030
Device Name TYRX Absorbable Antibacterial Envelope (medium), TYRX 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 Received01/03/2018
Decision Date 04/24/2018
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 Yes
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