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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 K160716
Device Name The Nanostim Introducer Kit
Applicant
St. Jude Medical, Inc.
645 Almanor Ave.
Sunnyvale,  CA  94085
Applicant Contact Brittany Cunningham
Correspondent
St. Jude Medical, Inc.
645 Almanor Ave.
Sunnyvale,  CA  94085
Correspondent Contact Hassan Labay
Regulation Number870.1340
Classification Product Code
DYB  
Date Received03/15/2016
Decision Date 04/14/2016
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Special
Reviewed by Third Party No
Combination Product No
Predetermined Change
Control Plan Authorized		 No
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