BD Univia RightFit Enteral Extension Sets And Transitional Adapters

Gastrointestinal Tubes With Enteral Specific Connectors

MPS Medical, Inc.

The following data is part of a premarket notification filed by Mps Medical, Inc. with the FDA for Bd Univia Rightfit Enteral Extension Sets And Transitional Adapters.

Pre-market Notification Details

Device IDK200082
510k NumberK200082
Device Name:BD Univia RightFit Enteral Extension Sets And Transitional Adapters
ClassificationGastrointestinal Tubes With Enteral Specific Connectors
Applicant MPS Medical, Inc. 830 Challenger Street, Suite 200 Brea,  CA  92821
ContactBarry Kazemi
CorrespondentPaul Gasser
MPS Medical, Inc. 830 Challenger Street, Suite 200 Brea,  CA  92821
Product CodePIF  
CFR Regulation Number876.5980 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-01-15
Decision Date2020-07-30

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