NIPRO SUREFUSER AMBULATORY INFUSION PUMP

Pump, Infusion, Elastomeric

NIPRO MEDICAL CORPORATION

The following data is part of a premarket notification filed by Nipro Medical Corporation with the FDA for Nipro Surefuser Ambulatory Infusion Pump.

Pre-market Notification Details

Device IDK051828
510k NumberK051828
Device Name:NIPRO SUREFUSER AMBULATORY INFUSION PUMP
ClassificationPump, Infusion, Elastomeric
Applicant NIPRO MEDICAL CORPORATION 1384 COPPERFIELD COURT Lexington,  KY  40514
ContactKaelyn Hadley
CorrespondentKaelyn Hadley
NIPRO MEDICAL CORPORATION 1384 COPPERFIELD COURT Lexington,  KY  40514
Product CodeMEB  
CFR Regulation Number880.5725 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2005-07-06
Decision Date2005-12-15
Summary:summary

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