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U.S. Department of Health and Human Services

510(k) Premarket Notification
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Device Classification Name cable, transducer and electrode, patient, (including connector)
510(k) Number K132253
Device Name REMOVABLE PATIENT LEADS ECG CABLE
Applicant
BOSTON SCIENTIFIC
4100 HAMLINE AVE
ARDEN HILLS,  MN  55112
Applicant Contact MELISSA KLAMERUS
Correspondent
BOSTON SCIENTIFIC
4100 HAMLINE AVE
ARDEN HILLS,  MN  55112
Correspondent Contact MELISSA KLAMERUS
Regulation Number870.2900
Classification Product Code
DSA  
Date Received07/19/2013
Decision Date 12/16/2013
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty Cardiovascular
510k Review Panel Cardiovascular
Summary Summary
Type Traditional
Reviewed by Third Party No
Combination Product No
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