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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 K122138
Device Name ATRIUM FLIXENE IFG VASCULAR GRAFT
Applicant
ATRIUM MEDICAL CORP.
5 WENTWORTH DR
HUDSON,  NH  03051
Applicant Contact MEGAN MCCAGH
Correspondent
ATRIUM MEDICAL CORP.
5 WENTWORTH DR
HUDSON,  NH  03051
Correspondent Contact MEGAN MCCAGH
Regulation Number870.3450
Classification Product Code
DSY  
Date Received07/19/2012
Decision Date 08/17/2012
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Special
Reviewed by Third Party No
Combination Product No
Recalls CDRH Recalls
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