FDA 510(k) Application Details - K052722

Device Classification Name Set, Administration, Intravascular

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510(K) Number K052722
Device Name Set, Administration, Intravascular
Applicant HOSPIRA, INC.
275 NORTH FIELD DR.
LAKE FOREST, IL 60045 US
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Contact THOMAS KOZMA
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Regulation Number 880.5440

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Classification Product Code FPA
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Date Received 09/29/2005
Decision Date 11/02/2005
Decision SESU - SE - WITH LIMITATIONS
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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