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FDA 510(k) Application Details - K963663
Device Classification Name
Catheter, Percutaneous
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510(K) Number
K963663
Device Name
Catheter, Percutaneous
Applicant
BOSTON SCIENTIFIC /INTERNATIONAL TECHNOLOGIES
3574 RUFFIN RD.
SAN DIEGO, CA 92123 US
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Contact
MICHAEL E KLICPERA
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Regulation Number
870.1250
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Classification Product Code
DQY
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More FDA Info for this Product Code
Date Received
09/13/1996
Decision Date
01/13/1997
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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