FDA 510(k) Application Details - K982020

Device Classification Name Pump, Infusion

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510(K) Number K982020
Device Name Pump, Infusion
Applicant METRON U.S., INC.
P O BOX 4341
CROFTON, MD 21114-4341 US
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Contact E.J. Smith
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Regulation Number 880.5725

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Classification Product Code FRN
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Date Received 06/09/1998
Decision Date 09/30/1998
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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