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FDA 510(k) Application Details - K021964
Device Classification Name
Pump, Infusion, Elastomeric
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510(K) Number
K021964
Device Name
Pump, Infusion, Elastomeric
Applicant
ADVANCED INFUSION, INC.
6200 SOUTH MCCLINTOCK #6
TEMPE, AZ 85283 US
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Contact
JAMES CHRISTENSEN
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Regulation Number
880.5725
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Classification Product Code
MEB
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More FDA Info for this Product Code
Date Received
06/14/2002
Decision Date
08/12/2002
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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