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FDA 510(k) Application Details - K053019
Device Classification Name
Stylet, Catheter
More FDA Info for this Device
510(K) Number
K053019
Device Name
Stylet, Catheter
Applicant
GUIDANT CORPORATION
4100 HAMLINE AVE NORTH
ST PAUL, MN 55112-5798 US
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Contact
JENNIFER X TANG
Other 510(k) Applications for this Contact
Regulation Number
870.1380
More FDA Info for this Regulation Number
Classification Product Code
DRB
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More FDA Info for this Product Code
Date Received
10/26/2005
Decision Date
03/03/2006
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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