IV Administration Sets

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 Sets.

Pre-market Notification Details

Device IDK202618
510k NumberK202618
Device Name:IV Administration Sets
ClassificationSet, Administration, Intravascular
Applicant B. Braun Medical Inc. 901 Marcon Blvd. Allentown,  PA  18109 -9341
ContactKimberly Smith
CorrespondentKimberly Smith
B. Braun Medical Inc. 901 Marcon Blvd. Allentown,  PA  18109 -9341
Product CodeFPA  
CFR Regulation Number880.5440 [🔎]
DecisionSubstantially Equivalent (SESE)
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2020-09-10
Decision Date2021-09-24

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