FDA 510(k) Application Details - K093773

Device Classification Name Set, Administration, Intravascular

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510(K) Number K093773
Device Name Set, Administration, Intravascular
Applicant AMSINO INTERNATIONAL, INC.
855 TOWNE CENTER DR.
POMONA, CA 91767 US
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Contact JESUS FARINAS
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Regulation Number 880.5440

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Classification Product Code FPA
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Date Received 12/08/2009
Decision Date 03/10/2010
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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