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FDA 510(k)

Omnifix Low Dead Space Luer Lock Syringe

K-Number: K193101 · 2020-03-05

Decision Date2020-03-05
Product CodeFMF
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Omnifix Low Dead Space Luer Lock Syringe is a medical device manufactured by B.Braun Medical, Inc.. It received FDA 510(k) clearance on 2020-03-05 under approval number K193101. The device is classified under product code FMF. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Omnifix Low Dead Space Luer Lock Syringe?

Omnifix Low Dead Space Luer Lock Syringe is a medical device that received FDA 510(k) clearance on 2020-03-05. It is manufactured by B.Braun Medical, Inc.. The 510(k) number is K193101.

When was Omnifix Low Dead Space Luer Lock Syringe approved by the FDA?

Omnifix Low Dead Space Luer Lock Syringe received FDA 510(k) clearance on 2020-03-05, under approval number K193101.

What company makes Omnifix Low Dead Space Luer Lock Syringe?

Omnifix Low Dead Space Luer Lock Syringe is manufactured by B.Braun Medical, Inc..

What is the FDA product code for Omnifix Low Dead Space Luer Lock Syringe?

The FDA product code for Omnifix Low Dead Space Luer Lock Syringe is FMF.

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Official Source

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Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.