FDA 510(k) Application Details - K172591

Device Classification Name Cable, Transducer And Electrode, Patient, (Including Connector)

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510(K) Number K172591
Device Name Cable, Transducer And Electrode, Patient, (Including Connector)
Applicant Boston Scientific Corporation
4100 Hamline Avenue North
St. Paul, MN 55112 US
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Contact Elizabeth A. Lisowski
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Regulation Number 870.2900

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Classification Product Code DSA
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Date Received 08/29/2017
Decision Date 11/03/2017
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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