FDA 510(k) Application Details - K023098

Device Classification Name Pump, Infusion, Elastomeric

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510(K) Number K023098
Device Name Pump, Infusion, Elastomeric
Applicant MCKINLEY INFUSER
631 HOWARD #202
SAN FRANCISCO, CA 94105 US
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Contact JOHN CHAPPELL
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Regulation Number 880.5725

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Classification Product Code MEB
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Date Received 09/18/2002
Decision Date 12/09/2002
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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