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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Catheter, Intravascular Occluding, Temporary
510(k) Number K053440
Device Name AMPLATZER SIZING BALLOON II
Applicant
Aga Medical Corp.
682 Mendelssohn Ave.
Plymouth,  MN  55427
Applicant Contact AMANDA JOHNSON
Correspondent
Aga Medical Corp.
682 Mendelssohn Ave.
Plymouth,  MN  55427
Correspondent Contact AMANDA JOHNSON
Regulation Number870.4450
Classification Product Code
MJN  
Date Received12/09/2005
Decision Date 12/30/2005
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
Recalls CDRH Recalls
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