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FDA 510(k) Application Details - K051568
Device Classification Name
Pump, Infusion
More FDA Info for this Device
510(K) Number
K051568
Device Name
Pump, Infusion
Applicant
SMITHS MEDICAL MD, INC.
1265 GREY FOX RD.
ST. PAUL, MN 55112 US
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Contact
MELANIE HESS
Other 510(k) Applications for this Contact
Regulation Number
880.5725
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Classification Product Code
FRN
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More FDA Info for this Product Code
Date Received
06/14/2005
Decision Date
11/17/2005
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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