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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 K100076
Device Name ATRIUM C-QUR OVT MESH
Applicant
ATRIUM MEDICAL CORP.
5 WENTWORTH DR.
HUDSON,  NH  03051
Applicant Contact Jacqueline Emery
Correspondent
ATRIUM MEDICAL CORP.
5 WENTWORTH DR.
HUDSON,  NH  03051
Correspondent Contact Jacqueline Emery
Regulation Number878.3300
Classification Product Code
FTL  
Date Received01/12/2010
Decision Date 01/26/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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