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FDA 510(k) Application Details - K963988
Device Classification Name
Catheter, Continuous Flush
More FDA Info for this Device
510(K) Number
K963988
Device Name
Catheter, Continuous Flush
Applicant
BOSTON SCIENTIFIC CORP.
ONE BOSTON SCIENTIFIC PL.
NATICK, MA 01760-1537 US
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Contact
MARY P LEGRAW
Other 510(k) Applications for this Contact
Regulation Number
870.1210
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Classification Product Code
KRA
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More FDA Info for this Product Code
Date Received
10/04/1996
Decision Date
12/12/1996
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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