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FDA 510(k)

TrueTear Intranasal Tear Neurostimulator

K-Number: K193589 · 2020-08-31

ApplicantAllergan
Decision Date2020-08-31
Product CodeQBR
Advisory CommitteeOP
DecisionSubstantially Equivalent

Device Summary

TrueTear Intranasal Tear Neurostimulator is a medical device manufactured by Allergan. It received FDA 510(k) clearance on 2020-08-31 under approval number K193589. The device is classified under product code QBR. It was reviewed by the OP advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TrueTear Intranasal Tear Neurostimulator?

TrueTear Intranasal Tear Neurostimulator is a medical device that received FDA 510(k) clearance on 2020-08-31. It is manufactured by Allergan. The 510(k) number is K193589.

When was TrueTear Intranasal Tear Neurostimulator approved by the FDA?

TrueTear Intranasal Tear Neurostimulator received FDA 510(k) clearance on 2020-08-31, under approval number K193589.

What company makes TrueTear Intranasal Tear Neurostimulator?

TrueTear Intranasal Tear Neurostimulator is manufactured by Allergan.

What is the FDA product code for TrueTear Intranasal Tear Neurostimulator?

The FDA product code for TrueTear Intranasal Tear Neurostimulator is QBR.

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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.