FDA 510(k) Application Details - K992015

Device Classification Name Pump, Infusion, Elastomeric

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510(K) Number K992015
Device Name Pump, Infusion, Elastomeric
Applicant NOVACON CORP.
5451 HILLTOP AVE.
LAKE ELMO, MN 55042 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 06/15/1999
Decision Date 09/10/1999
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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