FDA 510(k) Application Details - K072955

Device Classification Name Accessories, Pump, Infusion

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510(K) Number K072955
Device Name Accessories, Pump, Infusion
Applicant SMITHS MEDICAL MD, INC.
1265 GREY FOX RD.
ST. PAUL, MN 55112 US
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Contact DAVID H SHORT
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Regulation Number 880.5725

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Classification Product Code MRZ
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Date Received 10/19/2007
Decision Date 02/13/2008
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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