IV Administration Set

Set, Administration, Intravascular

B.Braun Medical Inc.

The following data is part of a premarket notification filed by B.braun Medical Inc. with the FDA for Iv Administration Set.

Pre-market Notification Details

Device IDK173361
510k NumberK173361
Device Name:IV Administration Set
ClassificationSet, Administration, Intravascular
Applicant B.Braun Medical Inc. 901 Marcon Blvd Allentown,  PA  18109
ContactNancy Skocypec
CorrespondentNancy Skocypec
B.Braun Medical Inc. 901 Marcon Blvd Allentown,  PA  18109
Product CodeFPA  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2017-10-26
Decision Date2018-06-26
Summary:summary

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