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FDA 510(k) Application Details - K173837
Device Classification Name
Computer, Diagnostic, Programmable
More FDA Info for this Device
510(K) Number
K173837
Device Name
Computer, Diagnostic, Programmable
Applicant
Boston Scientific Corporation
125 Cambridgepark Drive
Suite 600
Cambridge, MA 02140 US
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Contact
Gregory Neal
Other 510(k) Applications for this Contact
Regulation Number
870.1425
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Classification Product Code
DQK
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More FDA Info for this Product Code
Date Received
12/18/2017
Decision Date
07/25/2018
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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