FDA 510(k) Application Details - K955849

Device Classification Name Pump, Infusion, Elastomeric

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510(K) Number K955849
Device Name Pump, Infusion, Elastomeric
Applicant NOVACON CORP.
2514 SEVENTH AVENUE EAST
SUITE 11
ST.PAUL, MN 55109 US
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Contact DAVID P LANG
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Regulation Number 880.5725

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Classification Product Code MEB
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Date Received 12/27/1995
Decision Date 08/05/1996
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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