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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name device, vascular, for promoting embolization
510(k) Number K113658
Device Name AMPLATZER VASCULAR PLUG 4
Applicant
AGA MEDICAL CORP.
5050 nathan lane north
plymouth,  MN  55442
Applicant Contact sherry kollmann
Correspondent
AGA MEDICAL CORP.
5050 nathan lane north
plymouth,  MN  55442
Correspondent Contact sherry kollmann
Regulation Number870.3300
Classification Product Code
KRD  
Date Received12/12/2011
Decision Date 06/12/2012
Decision substantially equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
summary summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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