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FDA 510(k) Application Details - K150235
Device Classification Name
Amplifier And Signal Conditioner, Transducer Signal
More FDA Info for this Device
510(K) Number
K150235
Device Name
Amplifier And Signal Conditioner, Transducer Signal
Applicant
BOSTON SCIENTIFIC CORPORATION
55 TECHNOLOGY DRIVE
LOWELL, MA 01851 US
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Contact
MAYLIN TRUESDELL
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Regulation Number
870.2060
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Classification Product Code
DRQ
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More FDA Info for this Product Code
Date Received
02/02/2015
Decision Date
04/22/2015
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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