3DMax MID Anatomical Mesh

Mesh, Surgical, Polymeric

C.R. Bard, Inc.

The following data is part of a premarket notification filed by C.r. Bard, Inc. with the FDA for 3dmax Mid Anatomical Mesh.

Pre-market Notification Details

Device IDK200818
510k NumberK200818
Device Name:3DMax MID Anatomical Mesh
ClassificationMesh, Surgical, Polymeric
Applicant C.R. Bard, Inc. 100 Crossings Boulevard Warwick,  RI  02886
ContactShannon Green
CorrespondentShannon Green
C.R. Bard, Inc. 100 Crossings Boulevard Warwick,  RI  02886
Product CodeFTL  
CFR Regulation Number878.3300 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-03-30
Decision Date2020-07-17

NIH GUDID Devices

Device IdentifiersubmissionNumberSupplement
00801741200748 K200818 000
00801741200755 K200818 000
00801741200762 K200818 000
00801741200779 K200818 000
00801741200786 K200818 000
00801741200793 K200818 000
00801741200748 K200818 000
00801741200755 K200818 000
00801741200762 K200818 000
00801741200779 K200818 000
00801741200786 K200818 000
00801741200793 K200818 000
00801741200748 K200818 000
00801741200755 K200818 000
00801741200762 K200818 000
00801741200779 K200818 000
00801741200786 K200818 000
00801741200748 K200818 000
00801741200793 K200818 000
00801741200755 K200818 000
00801741200762 K200818 000
00801741200779 K200818 000
00801741200786 K200818 000
00801741200793 K200818 000
00801741200748 K200818 000
00801741200755 K200818 000
00801741200762 K200818 000
00801741200779 K200818 000
00801741200786 K200818 000
00801741200793 K200818 000
00801741200748 K200818 000
00801741200755 K200818 000
00801741200762 K200818 000
00801741200779 K200818 000
00801741200786 K200818 000
00801741200793 K200818 000
00801741200748 K200818 000
00801741200755 K200818 000
00801741200762 K200818 000
00801741200779 K200818 000
00801741200786 K200818 000
00801741200793 K200818 000
00801741200748 K200818 000
00801741200755 K200818 000
00801741200762 K200818 000
00801741200779 K200818 000
00801741200786 K200818 000
00801741200793 K200818 000
00801741200748 K200818 000
00801741200755 K200818 000
00801741200762 K200818 000
00801741200779 K200818 000
00801741200786 K200818 000
00801741200748 K200818 000
00801741200793 K200818 000
00801741200755 K200818 000
00801741200762 K200818 000
00801741200779 K200818 000
00801741200786 K200818 000
00801741200793 K200818 000
00801741200748 K200818 000
00801741200755 K200818 000
00801741200762 K200818 000
00801741200779 K200818 000
00801741200786 K200818 000
00801741200793 K200818 000
00801741200748 K200818 000
00801741200755 K200818 000
00801741200762 K200818 000
00801741200779 K200818 000
00801741200786 K200818 000
00801741200793 K200818 000

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