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FDA 510(k) Application Details - K113182
Device Classification Name
Clamp, Vascular
More FDA Info for this Device
510(K) Number
K113182
Device Name
Clamp, Vascular
Applicant
EDWARDS LIFESCIENCES, LLC.
12050 Lone Peak Pkwy
Draper, UT 84020 US
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Contact
SPENCER WALKER
Other 510(k) Applications for this Contact
Regulation Number
870.4450
More FDA Info for this Regulation Number
Classification Product Code
DXC
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
10/28/2011
Decision Date
12/07/2011
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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