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FDA 510(k) Application Details - K060449
Device Classification Name
Wire, Guide, Catheter
More FDA Info for this Device
510(K) Number
K060449
Device Name
Wire, Guide, Catheter
Applicant
GUIDANT CORPORATION
26531 YNEZ ROAD
TEMECULA, CA 92591 US
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Contact
JENNIFER PAE RIGGS
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
02/21/2006
Decision Date
05/30/2006
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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