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FDA 510(k)

True Function Adjustable Herbst Appliances

K-Number: K170578 · 2017-11-24

ApplicantTrue Function Laboratory, Inc.
Decision Date2017-11-24
Product CodeLRK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

True Function Adjustable Herbst Appliances is the device name listed in this FDA 510(k) record. The listed applicant is True Function Laboratory, Inc.. It received FDA 510(k) clearance on 2017-11-24 under 510(k) number K170578. 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 True Function Adjustable Herbst Appliances?

True Function Adjustable Herbst Appliances is a medical device that received FDA 510(k) clearance on 2017-11-24. The listed applicant is True Function Laboratory, Inc.. The 510(k) number is K170578.

When did True Function Adjustable Herbst Appliances receive FDA 510(k) clearance?

True Function Adjustable Herbst Appliances received FDA 510(k) clearance on 2017-11-24, under 510(k) number K170578.

Who is the listed applicant for True Function Adjustable Herbst Appliances?

The FDA 510(k) record lists True Function Laboratory, Inc. as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for True Function Adjustable Herbst Appliances?

The FDA product code for True Function Adjustable Herbst Appliances is LRK.

Other records listing True Function Laboratory, Inc. as applicant

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.

K180691TrueDorsal Devices

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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