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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Trocar
510(k) Number K072278
Device Name BRK TRANSSEPTAL NEEDLE
Applicant
St Jude Medical
14901 Deveau Pl.
Minnetonka,  MN  55345 -2126
Applicant Contact Laura Moen-Ftacek
Correspondent
Regulatory Technology Services, LLC
1000 Westgate Dr. Suite #510k
Saint Paul,  MN  55114
Correspondent Contact MARK JOB
Regulation Number870.1390
Classification Product Code
DRC  
Date Received08/16/2007
Decision Date 09/13/2007
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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