FDA 510(k) Application Details - K991437

Device Classification Name Pump, Infusion

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510(K) Number K991437
Device Name Pump, Infusion
Applicant WELLS JOHNSON CO.
8000 SOUTH KOLB RD.
TUCSON, AZ 85706 US
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Contact KEN RODENBURG
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Regulation Number 880.5725

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Classification Product Code FRN
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Date Received 04/26/1999
Decision Date 08/30/1999
Decision SESE - SUBST EQUIV
Classification Advisory Committee HO - General Hospital
Review Advisory Committee HO - General Hospital
Statement / Summary / Purged Status Statement
Type Traditional
Reviewed By Third Party N
Expedited Review



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