FDA 510(k) Application Details - K142974

Device Classification Name Set, Administration, Intravascular

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510(K) Number K142974
Device Name Set, Administration, Intravascular
Applicant Hospira, Inc
375 North Field Drive
Lake Forest, IL 60045 US
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Contact David Blonski
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Regulation Number 880.5440

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Classification Product Code FPA
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Date Received 10/14/2014
Decision Date 01/09/2015
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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