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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 K170294
Device Name VENTRALIGHT ST Mesh with ECHO 2 Positioning System 11cm (4.5”) Circle, VENTRALIGHT ST Mesh with ECHO 2 Positioning System 10cm x 15cm (4”x 6”) Ellipse, VENTRALIGHT ST Mesh with ECHO 2 Positioning System 15cm (6”) Circle, VENTRALIGHT ST Mesh with ECHO 2 Positioning System 15cm x 20cm (6”x8”) Ellips
Applicant
CR BARD
100 CROSSING BLVD
WARWICK,  RI  02886
Applicant Contact CHRISTINE LLOYD
Correspondent
CR BARD
100 CROSSING BLVD
WARWICK,  RI  02886
Correspondent Contact CHRISTINE LLOYD
Regulation Number878.3300
Classification Product Code
FTL  
Subsequent Product Codes
GCJ   ORQ  
Date Received01/31/2017
Decision Date 05/01/2017
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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