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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Wire, Guide, Catheter
510(k) Number K053187
Device Name AMPLATZER NOODLEWIRE GUIDEWIRE
Applicant
Aga Medical Corp.
682 Mendelssohn Ave.
Plymouth,  MN  55427
Applicant Contact PATRICIA A LAFORET
Correspondent
Aga Medical Corp.
682 Mendelssohn Ave.
Plymouth,  MN  55427
Correspondent Contact PATRICIA A LAFORET
Regulation Number870.1330
Classification Product Code
DQX  
Date Received11/15/2005
Decision Date 04/27/2006
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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