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FDA 510(k) Application Details - K042121
Device Classification Name
Pump, Infusion
More FDA Info for this Device
510(K) Number
K042121
Device Name
Pump, Infusion
Applicant
SIGMA INTL.
711 PARK AVE.
MEDINA, NY 14103-0756 US
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Contact
CHARLES L MARTINA
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
08/06/2004
Decision Date
08/26/2004
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
Y
Expedited Review
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