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FDA 510(k) Application Details - K172591
Device Classification Name
Cable, Transducer And Electrode, Patient, (Including Connector)
More FDA Info for this Device
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
Other 510(k) Applications for this Contact
Regulation Number
870.2900
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Classification Product Code
DSA
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More FDA Info for this Product Code
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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