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FDA 510(k) Application Details - K073162
Device Classification Name
Wire, Guide, Catheter
More FDA Info for this Device
510(K) Number
K073162
Device Name
Wire, Guide, Catheter
Applicant
KENSEY NASH CORPORATION
735 PENNSYLVANIA DRIVE
EXTON, PA 19341 US
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Contact
ROBIN FATZINGER
Other 510(k) Applications for this Contact
Regulation Number
870.1330
More FDA Info for this Regulation Number
Classification Product Code
DQX
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
11/09/2007
Decision Date
02/08/2008
Decision
SESE - SUBST EQUIV
Classification Advisory Committee
CV - Cardiovascular
Review Advisory Committee
CV - Cardiovascular
Statement / Summary / Purged Status
Summary
Type
Special
Reviewed By Third Party
N
Expedited Review
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