FDA 510(k) Application Details - K021565

Device Classification Name Set, Administration, Intravascular

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510(K) Number K021565
Device Name Set, Administration, Intravascular
Applicant LUTHER RESEARCH PARTNERS
3722 AVE. SAUSALITO
IRVINE, CA 92606 US
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Contact GREY HOLLAND
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Regulation Number 880.5440

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Classification Product Code FPA
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Date Received 05/13/2002
Decision Date 11/14/2002
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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