FDA 510(k) Application Details - K013767

Device Classification Name Pump, Infusion

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510(K) Number K013767
Device Name Pump, Infusion
Applicant STERLING MEDIVATIONS, INC.
25285 LA LOMA DR.
LOS ALTOS HILLS, CA 94022-4583 US
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Contact JOEL DOUGLAS
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Regulation Number 880.5725

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Classification Product Code FRN
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Date Received 11/13/2001
Decision Date 12/12/2001
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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