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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Stylet, Catheter
510(k) Number K090163
Device Name STYLET, MODELS 4060, 4062, 4064, 4090, 4091 AND 4078
Applicant
St Jude Medical
15900 Valley View Ct.
Sylmar,  CA  91342
Applicant Contact GEENA GEORGE
Correspondent
St Jude Medical
15900 Valley View Ct.
Sylmar,  CA  91342
Correspondent Contact GEENA GEORGE
Regulation Number870.1380
Classification Product Code
DRB  
Date Received01/22/2009
Decision Date 04/01/2009
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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