FDA 510(k) Application Details - K063180

Device Classification Name Adaptor, Holder, Syringe

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510(K) Number K063180
Device Name Adaptor, Holder, Syringe
Applicant HOSPIRA, INC.
275 N. FIELD DR., BLDG. H-2
DEPT. 389
LAKE FOREST, IL 60045 US
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Contact DIANE RENNPFERD
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Regulation Number 890.5050

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Classification Product Code IQG
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Date Received 10/19/2006
Decision Date 12/11/2006
Decision SESE - SUBST EQUIV
Classification Advisory Committee PM - Physical Medicine
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Summary
Type Special
Reviewed By Third Party N
Expedited Review



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