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FDA 510(k) Application Details - K210889
Device Classification Name
Computer, Diagnostic, Programmable
More FDA Info for this Device
510(K) Number
K210889
Device Name
Computer, Diagnostic, Programmable
Applicant
Boston Scientific Corporation
Three Scimed Place
Maple Grove Hennepin, MN 55311 US
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Contact
Rochell Aranha
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
03/25/2021
Decision Date
06/25/2021
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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