FDA 510(k) Application Details - K132253

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

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510(K) Number K132253
Device Name Cable, Transducer And Electrode, Patient, (Including Connector)
Applicant BOSTON SCIENTIFIC
4100 HAMLINE AVE
ARDEN HILLS, MN 55112 US
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Contact MELISSA KLAMERUS
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Regulation Number 870.2900

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Classification Product Code DSA
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Date Received 07/19/2013
Decision Date 12/16/2013
Decision SESE - SUBST EQUIV
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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