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FDA 510(k) Application Details - K981776
Device Classification Name
Pump, Infusion
More FDA Info for this Device
510(K) Number
K981776
Device Name
Pump, Infusion
Applicant
ALEXANDER MFG. CO.
1511 S GARFIELD PL
MASON CITY, IA 50401 US
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Contact
KEN HEIMENDINGER
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
05/20/1998
Decision Date
08/03/1998
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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