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FDA 510(k) Application Details - K982838
Device Classification Name
Pump, Infusion
More FDA Info for this Device
510(K) Number
K982838
Device Name
Pump, Infusion
Applicant
SIMS DELTEC, INC.
1265 GREY FOX RD.
ST. PAUL, MN 55112 US
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Contact
EDWARD W NUMAINVILLE
Other 510(k) Applications for this Contact
Regulation Number
880.5725
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Classification Product Code
FRN
Other 510(k) Applications for this Device
More FDA Info for this Product Code
Date Received
08/12/1998
Decision Date
11/04/1998
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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