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FDA 510(k)

TONGUE STABILIZER DEVICE

K-Number: K993381 · 1999-12-21

ApplicantUniversity of Otago
Decision Date1999-12-21
Product CodeLRK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

TONGUE STABILIZER DEVICE is the device name listed in this FDA 510(k) record. The listed applicant is University of Otago. It received FDA 510(k) clearance on 1999-12-21 under 510(k) number K993381. 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 TONGUE STABILIZER DEVICE?

TONGUE STABILIZER DEVICE is a medical device that received FDA 510(k) clearance on 1999-12-21. The listed applicant is University of Otago. The 510(k) number is K993381.

When did TONGUE STABILIZER DEVICE receive FDA 510(k) clearance?

TONGUE STABILIZER DEVICE received FDA 510(k) clearance on 1999-12-21, under 510(k) number K993381.

Who is the listed applicant for TONGUE STABILIZER DEVICE?

The FDA 510(k) record lists University of Otago as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for TONGUE STABILIZER DEVICE?

The FDA product code for TONGUE STABILIZER DEVICE is LRK.

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Related Devices (Code: LRK)

Related records are matched automatically using names, product codes, or other metadata. A match does not establish a verified clinical, scientific, corporate, or regulatory relationship; review the linked official sources.

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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.

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