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FDA 510(k) Application Details - K071532
Device Classification Name
Pump, Infusion, Elastomeric
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510(K) Number
K071532
Device Name
Pump, Infusion, Elastomeric
Applicant
ADVANCED INFUSION, INC.
466 WEST ARROW HWY., UNIT H
SAN DIMAS, CA 91773 US
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Contact
JAMES CHRISTENSEN
Other 510(k) Applications for this Contact
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
06/05/2007
Decision Date
02/19/2008
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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