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FDA 510(k) Application Details - K961999
Device Classification Name
Catheter, Flow Directed
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510(K) Number
K961999
Device Name
Catheter, Flow Directed
Applicant
BOSTON SCIENTIFIC SCIMED, INC.
5905 NATHAN LN.
MINNEAPOLIS, MN 55442 US
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Contact
MARIA BRITTLE
Other 510(k) Applications for this Contact
Regulation Number
870.1240
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Classification Product Code
DYG
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More FDA Info for this Product Code
Date Received
05/22/1996
Decision Date
11/19/1996
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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