MPS RESERVOIR BAG

Container, I.v.

MEDICAL PRODUCT SPECIALISTS

The following data is part of a premarket notification filed by Medical Product Specialists with the FDA for Mps Reservoir Bag.

Pre-market Notification Details

Device IDK982048
510k NumberK982048
Device Name:MPS RESERVOIR BAG
ClassificationContainer, I.v.
Applicant MEDICAL PRODUCT SPECIALISTS 499 NIBUS ST., SUITE E Brea,  CA  92821
ContactDan Hyun
CorrespondentDan Hyun
MEDICAL PRODUCT SPECIALISTS 499 NIBUS ST., SUITE E Brea,  CA  92821
Product CodeKPE  
CFR Regulation Number880.5025 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received1998-06-10
Decision Date1998-07-27
Summary:summary

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