FDA 510(k) Application Details - K072144

Device Classification Name Pump, Infusion, Pca

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510(K) Number K072144
Device Name Pump, Infusion, Pca
Applicant SMITHS MEDICAL MD, INC.
1265 GREY FOX RD.
ARDEN HILLS, MN 55112 US
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Contact PHIL NEURURER
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Regulation Number 880.5725

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Classification Product Code MEA
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Date Received 08/02/2007
Decision Date 03/07/2008
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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