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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 K200818
Device Name 3DMax MID Anatomical Mesh
Applicant
C.R. Bard, Inc.
100 Crossings Boulevard
warwick,  RI  02886
Applicant Contact shannon green
Correspondent
C.R. Bard, Inc.
100 Crossings Boulevard
warwick,  RI  02886
Correspondent Contact shannon green
Regulation Number878.3300
Classification Product Code
FTL  
Date Received03/30/2020
Decision Date 07/17/2020
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
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