FDA 510(k) Application Details - K060119

Device Classification Name Pump, Infusion

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510(K) Number K060119
Device Name Pump, Infusion
Applicant MCKINLEY MEDICAL LLC
4080 YOUNGFIELD
WHEAT RIDGE, CO 80033 US
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Contact JOHN CHAPPELL
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Regulation Number 880.5725

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Classification Product Code FRN
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Date Received 01/17/2006
Decision Date 04/12/2006
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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