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FDA 510(k) Application Details - K123551
Device Classification Name
Clamp, Vascular
More FDA Info for this Device
510(K) Number
K123551
Device Name
Clamp, Vascular
Applicant
INNOVATIVE TRAUMA CARE INC
3463 MAGIC DR.
SUITE 120
SAN ANTONIO, TX 78229 US
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Contact
RICHARD WAITE
Other 510(k) Applications for this Contact
Regulation Number
870.4450
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Classification Product Code
DXC
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More FDA Info for this Product Code
Date Received
11/19/2012
Decision Date
05/14/2013
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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