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FDA 510(k)

Unger Quad Injector

K-Number: K161483 · 2016-10-31

ApplicantStradis Healthcare
Decision Date2016-10-31
Product CodeLCJ
DecisionSubstantially Equivalent

Device Summary

Unger Quad Injector is a medical device manufactured by Stradis Healthcare. It received FDA 510(k) clearance on 2016-10-31 under approval number K161483. The device is classified under product code LCJ. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Unger Quad Injector?

Unger Quad Injector is a medical device that received FDA 510(k) clearance on 2016-10-31. It is manufactured by Stradis Healthcare. The 510(k) number is K161483.

When was Unger Quad Injector approved by the FDA?

Unger Quad Injector received FDA 510(k) clearance on 2016-10-31, under approval number K161483.

What company makes Unger Quad Injector?

Unger Quad Injector is manufactured by Stradis Healthcare.

What is the FDA product code for Unger Quad Injector?

The FDA product code for Unger Quad Injector is LCJ.

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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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