FDA 510(k) Application Details - K935184

Device Classification Name System, Balloon, Intra-Aortic And Control

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510(K) Number K935184
Device Name System, Balloon, Intra-Aortic And Control
Applicant ST. JUDE MEDICAL, INC.
12 ELIZABETH DR.
CHELMSFORD, MA US
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Contact SAMUEL D WADE
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Regulation Number 870.3535

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Classification Product Code DSP
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Date Received 10/26/1993
Decision Date 02/10/1995
Decision SE - Substantially Equivalent
Classification Advisory Committee CV - Cardiovascular
Review Advisory Committee CV - Cardiovascular
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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