FDA 510(k) Application Details - K140805

Device Classification Name Clamp, Vascular

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510(K) Number K140805
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
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Regulation Number 870.4450

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Classification Product Code DXC
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Date Received 04/01/2014
Decision Date 10/09/2014
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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