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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Patch, Pledget And Intracardiac, Petp, Ptfe, Polypropylene
510(k) Number K060396
Device Name IVENA VASCULAR PATCH
Applicant
Atrium Medical Corp.
5 Wentworth Dr.
Hudson,  NH  03051
Applicant Contact JOSEPH P DE PAOLO
Correspondent
Atrium Medical Corp.
5 Wentworth Dr.
Hudson,  NH  03051
Correspondent Contact JOSEPH P DE PAOLO
Regulation Number870.3470
Classification Product Code
DXZ  
Date Received02/15/2006
Decision Date 05/12/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Statement Statement
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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