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FDA 510(k)

Fuselier Intraoral Nighttime Device (FIND)

K-Number: K161980 · 2017-02-07

ApplicantFuselier Enterprises, LLC
Decision Date2017-02-07
Product CodeLRK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

Fuselier Intraoral Nighttime Device (FIND) is a medical device manufactured by Fuselier Enterprises, LLC. It received FDA 510(k) clearance on 2017-02-07 under approval number K161980. The device is classified under product code LRK. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the Fuselier Intraoral Nighttime Device (FIND)?

Fuselier Intraoral Nighttime Device (FIND) is a medical device that received FDA 510(k) clearance on 2017-02-07. It is manufactured by Fuselier Enterprises, LLC. The 510(k) number is K161980.

When was Fuselier Intraoral Nighttime Device (FIND) approved by the FDA?

Fuselier Intraoral Nighttime Device (FIND) received FDA 510(k) clearance on 2017-02-07, under approval number K161980.

What company makes Fuselier Intraoral Nighttime Device (FIND)?

Fuselier Intraoral Nighttime Device (FIND) is manufactured by Fuselier Enterprises, LLC.

What is the FDA product code for Fuselier Intraoral Nighttime Device (FIND)?

The FDA product code for Fuselier Intraoral Nighttime Device (FIND) is LRK.

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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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