FDA 510(k) Application Details - K093271

Device Classification Name Set, Administration, Intravascular

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510(K) Number K093271
Device Name Set, Administration, Intravascular
Applicant VICTUS, INC.
4918 S.W. 74TH COURT
MIAMI, FL 33155 US
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Contact ILEANA YANES
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Regulation Number 880.5440

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Classification Product Code FPA
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Date Received 10/19/2009
Decision Date 01/27/2010
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Traditional
Reviewed By Third Party N
Expedited Review



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