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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 K182008
Device Name Phasix ST Mesh with Echo 2 Positioning System
Applicant
CR Bard Inc.
100 Crossing Boulevard
Warwick,  RI  02886
Applicant Contact Shirin Mate
Correspondent
CR Bard Inc.
100 Crossing Boulevard
Warwick,  RI  02886
Correspondent Contact Shirin Mate
Regulation Number878.3300
Classification Product Code
FTL  
Subsequent Product Codes
GCJ   OOD   ORQ   OWT  
Date Received07/27/2018
Decision Date 12/14/2018
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 No
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