FDA 510(k) Application Details - K092382

Device Classification Name Set, Administration, Intravascular

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510(K) Number K092382
Device Name Set, Administration, Intravascular
Applicant NEXUS MEDICAL, LLC
11315 STRANG LINE ROAD
LENEXA, KS 66215 US
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Contact SUSAN CURRY
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Regulation Number 880.5440

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Classification Product Code FPA
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Date Received 08/05/2009
Decision Date 04/26/2010
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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