FDA 510(k) Application Details - K041585

Device Classification Name Pump, Infusion, Elastomeric

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510(K) Number K041585
Device Name Pump, Infusion, Elastomeric
Applicant ALGOS, LC
150 LAKE VILLAGE DRIVE
SUITE 203
ANN ARBOR, MI 48103 US
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Contact ROBERT J BARD
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Regulation Number 880.5725

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Classification Product Code MEB
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Date Received 06/14/2004
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 N
Expedited Review



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