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FDA 510(k)

SOMNODENT HERBST; CLASSIC, FLEX

K-Number: K130558 · 2013-05-17

ApplicantSomnomed, Inc.
Decision Date2013-05-17
Product CodeLRK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SOMNODENT HERBST; CLASSIC, FLEX is the device name listed in this FDA 510(k) record. The listed applicant is Somnomed, Inc.. It received FDA 510(k) clearance on 2013-05-17 under 510(k) number K130558. 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 SOMNODENT HERBST; CLASSIC, FLEX?

SOMNODENT HERBST; CLASSIC, FLEX is a medical device that received FDA 510(k) clearance on 2013-05-17. The listed applicant is Somnomed, Inc.. The 510(k) number is K130558.

When did SOMNODENT HERBST; CLASSIC, FLEX receive FDA 510(k) clearance?

SOMNODENT HERBST; CLASSIC, FLEX received FDA 510(k) clearance on 2013-05-17, under 510(k) number K130558.

Who is the listed applicant for SOMNODENT HERBST; CLASSIC, FLEX?

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

What is the FDA product code for SOMNODENT HERBST; CLASSIC, FLEX?

The FDA product code for SOMNODENT HERBST; CLASSIC, FLEX is LRK.

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Other records listing Somnomed, 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.

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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

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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