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FDA 510(k)

Concert Medical Hands-Free Syringe (HFS)

K-Number: K153599 · 2016-09-01

ApplicantConcert Medical, LLC
Decision Date2016-09-01
Product CodeFRN
Advisory CommitteeHO
DecisionSubstantially Equivalent

Device Summary

Concert Medical Hands-Free Syringe (HFS) is a medical device manufactured by Concert Medical, LLC. It received FDA 510(k) clearance on 2016-09-01 under approval number K153599. The device is classified under product code FRN. It was reviewed by the HO advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Concert Medical Hands-Free Syringe (HFS)?

Concert Medical Hands-Free Syringe (HFS) is a medical device that received FDA 510(k) clearance on 2016-09-01. It is manufactured by Concert Medical, LLC. The 510(k) number is K153599.

When was Concert Medical Hands-Free Syringe (HFS) approved by the FDA?

Concert Medical Hands-Free Syringe (HFS) received FDA 510(k) clearance on 2016-09-01, under approval number K153599.

What company makes Concert Medical Hands-Free Syringe (HFS)?

Concert Medical Hands-Free Syringe (HFS) is manufactured by Concert Medical, LLC.

What is the FDA product code for Concert Medical Hands-Free Syringe (HFS)?

The FDA product code for Concert Medical Hands-Free Syringe (HFS) is FRN.

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Official Source

View on FDA Database →

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

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