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
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Regulation Number 880.5725

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Classification Product Code MEB
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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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