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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name prosthesis, vascular graft, of 6mm and greater diameter
510(k) Number K060124
Device Name ATRIUM FLIXENE GRAFT
Applicant
ATRIUM MEDICAL CORP.
5 WENTWORTH DR.
HUDSON,  NH  03051
Applicant Contact KAREN HALL
Correspondent
ATRIUM MEDICAL CORP.
5 WENTWORTH DR.
HUDSON,  NH  03051
Correspondent Contact KAREN HALL
Regulation Number870.3450
Classification Product Code
DSY  
Date Received01/18/2006
Decision Date 03/30/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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