FDA 510(k) Application Details - K020990

Device Classification Name Set, Administration, Intravascular

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510(K) Number K020990
Device Name Set, Administration, Intravascular
Applicant STERLING MEDIVATIONS, INC.
25285 LA LOMA DR.
LOS ALTOS HILLS, CA 94022-4583 US
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Contact JOEL DOUGLAS
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Regulation Number 880.5440

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Classification Product Code FPA
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Date Received 03/27/2002
Decision Date 04/10/2002
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Statement
Type Special
Reviewed By Third Party N
Expedited Review



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