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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 Dr. 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
Predetermined Change
Control Plan Authorized		 No
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