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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Introducer, Catheter
510(k) Number K140793
Device Name NANOSTIM INTRODUCER KIT
Applicant
St. Jude Medical, Inc.
776 Palomar Ave.
Sunnyvale,  CA  94085
Applicant Contact HASSAN LABAY
Correspondent
St. Jude Medical, Inc.
776 Palomar Ave.
Sunnyvale,  CA  94085
Correspondent Contact HASSAN LABAY
Regulation Number870.1340
Classification Product Code
DYB  
Date Received03/31/2014
Decision Date 12/17/2014
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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