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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 K013577
Device Name ULTRAMAX WOVEN VELOUR VASCULAR GRAFT
Applicant
ATRIUM MEDICAL CORP.
5 WENTWORTH DR.
HUDSON,  NH  03051
Applicant Contact JOSEPH P PAOLO
Correspondent
ATRIUM MEDICAL CORP.
5 WENTWORTH DR.
HUDSON,  NH  03051
Correspondent Contact JOSEPH P PAOLO
Regulation Number870.3450
Classification Product Code
DSY  
Date Received10/29/2001
Decision Date 01/25/2002
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
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