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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name catheter, percutaneous
510(k) Number K070238
Device Name AMPLATZER RELIANT CATHETER DELIVERY SYSTEM
Applicant
AGA MEDICAL CORP.
682 MENDELSSOHN AVE.
PLYMOUTH,  MN  55427
Applicant Contact DAVID D COX
Correspondent
REGULATORY TECHNOLOGY SERVICES, LLC
1000 Westgate Drive,
Suite 510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number870.1250
Classification Product Code
DQY  
Date Received01/25/2007
Decision Date 02/28/2007
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party Yes
Combination Product No
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