FDA 510(k) Application Details - K042405

Device Classification Name Pump, Infusion

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510(K) Number K042405
Device Name Pump, Infusion
Applicant STRYKER CORP.
4100 E. MILHAM AVE.
KALAMAZOO, MI 49001 US
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Contact JENNIFER MARS
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Regulation Number 880.5725

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Classification Product Code FRN
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Date Received 09/03/2004
Decision Date 10/14/2004
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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