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U.S. Department of Health and Human Services

510(k) Premarket Notification

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Device Classification Name analyzer, pacemaker generator function
510(k) Number K170815
Device Name PSA Cable
Applicant
Boston Scientific Corporation
4100 Hamline Ave North
st. paul,  MN  55112
Applicant Contact melissa klamerus
Correspondent
Boston Scientific Corporation
4100 Hamline Ave North
st. paul,  MN  55112
Correspondent Contact melissa klamerus
Regulation Number870.3630
Classification Product Code
DTC  
Date Received03/17/2017
Decision Date 07/06/2017
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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