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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name Syringe, Balloon Inflation
510(k) Number K140745
Device Name ENCORE 26 ADVANTAGE KIT
Applicant
Boston Scientific Corp
One Scimed Place
Maple Grove,  MN  55311 -1566
Applicant Contact LISA MEE
Correspondent
Boston Scientific Corp
One Scimed Place
Maple Grove,  MN  55311 -1566
Correspondent Contact LISA MEE
Regulation Number870.1650
Classification Product Code
MAV  
Date Received03/25/2014
Decision Date 04/17/2014
Decision Substantially Equivalent - Kit (SESK)
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
Recalls CDRH Recalls
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