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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 K121070
Device Name C-QUR RPM MESH
Applicant
Atrium Medical Corp.
5 Wentworth Dr.
Hudson,  NH  03051
Applicant Contact JOSEPH DEPAOLO
Correspondent
Atrium Medical Corp.
5 Wentworth Dr.
Hudson,  NH  03051
Correspondent Contact JOSEPH DEPAOLO
Regulation Number878.3300
Classification Product Code
FTL  
Subsequent Product Code
OXA  
Date Received04/09/2012
Decision Date 04/26/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General & Plastic Surgery
510k Review Panel General & Plastic Surgery
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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