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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 K151386
Device Name C-QUR, C-QUR FX, C-QUR TacShield, C-QUR V-Patch, C-QUR CentriFX, C-QUR Mosaic
Applicant
ATRIUM MEDICAL CORPORATION
5 WENTWORTH DR
hudson,  NH  03051
Applicant Contact timothy j talcott
Correspondent
ATRIUM MEDICAL CORPORATION
5 WENTWORTH DR
hudson,  NH  03051
Correspondent Contact timothy j talcott
Regulation Number878.3300
Classification Product Code
FTL  
Date Received05/26/2015
Decision Date 10/22/2015
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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