510(k) Premarket Notification

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New Search Back To Search Results Device Classification Name set, administration, intravascular 510(k) Number K002492 Device Name SIMPLICITY SOFT INFUSION SET Applicant STERLING MEDIVATIONS, INC. 180 ferndale rd. south wayzata,  MN  55391 Contact joel douglas Regulation Number 880.5440 Classification Product Code FPA   Date Received 08/14/2000 Decision Date 10/24/2000 Decision substantially equivalent (SE) Classification Advisory Committee General Hospital Review Advisory Committee General Hospital Statement/Summary/Purged Status Summary only summary summary Type Abbreviated Reviewed by Third Party No Expedited Review No