Omnifix Low Dead Space Luer Lock Syringe

Syringe, Piston

B. Braun Medical Inc.

The following data is part of a premarket notification filed by B. Braun Medical Inc. with the FDA for Omnifix Low Dead Space Luer Lock Syringe.

Pre-market Notification Details

Device IDK193101
510k NumberK193101
Device Name:Omnifix Low Dead Space Luer Lock Syringe
ClassificationSyringe, Piston
Applicant B. Braun Medical Inc. 901 Marcon Blvd. Allentown,  PA  18109
ContactTracy Larish
CorrespondentTracy Larish
B. Braun Medical Inc. 901 Marcon Blvd. Allentown,  PA  18109
Product CodeFMF  
CFR Regulation Number880.5860 [🔎]
DecisionSubstantially Equivalent (SESE)
Regulation Medical SpecialtyGeneral Hospital
510k Review PanelGeneral Hospital
TypeTraditional
3rd Party ReviewedNo
Combination ProductNo
Date Received2019-11-08
Decision Date2020-03-05

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