FDA 510(K) K100434, CLAVE NEUTRON
FDA 510(K) K100434, CLAVE NEUTRON
Device Classification Name Set, Administration, Intravascular
510(k) Number K100434
Device Name CLAVE NEUTRON
Applicant ICU MEDICAL, INC.
Regulation Number 880.5440
Classification Product Code FPA
Subsequent Product Code KGZ
Date Received 02/16/2010
Decision Date 07/09/2010
Decision Substantially Equivalent (SESE)
Regulation Medical Specialty General Hospital
Total pages: 623
Fully redacted pages: 463
Content pages: 160
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