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FDA 510(k)

LAMBERGSLEEPWELL- SMARTRUSION (LSW-S)

K-Number: K101709 · 2010-08-18

ApplicantSteven B. Lamberg, Dds
Decision Date2010-08-18
Product CodeLRK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

LAMBERGSLEEPWELL- SMARTRUSION (LSW-S) is the device name listed in this FDA 510(k) record. The listed applicant is Steven B. Lamberg, Dds. It received FDA 510(k) clearance on 2010-08-18 under 510(k) number K101709. 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 LAMBERGSLEEPWELL- SMARTRUSION (LSW-S)?

LAMBERGSLEEPWELL- SMARTRUSION (LSW-S) is a medical device that received FDA 510(k) clearance on 2010-08-18. The listed applicant is Steven B. Lamberg, Dds. The 510(k) number is K101709.

When did LAMBERGSLEEPWELL- SMARTRUSION (LSW-S) receive FDA 510(k) clearance?

LAMBERGSLEEPWELL- SMARTRUSION (LSW-S) received FDA 510(k) clearance on 2010-08-18, under 510(k) number K101709.

Who is the listed applicant for LAMBERGSLEEPWELL- SMARTRUSION (LSW-S)?

The FDA 510(k) record lists Steven B. Lamberg, Dds as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for LAMBERGSLEEPWELL- SMARTRUSION (LSW-S)?

The FDA product code for LAMBERGSLEEPWELL- SMARTRUSION (LSW-S) 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.

K262104Anti Snoring Mouthpiece (L09-BB, L09-PP, L09-TB, L09-BT, L09-TP, L09-PT, L09-TT)Ram.Shaw Pte., Ltd.K261912SnØreNegatØrDnB Innovations, LLCK261366VirtusSomnomed, Inc.K261251Snorbliss® Anti-Snoring DeviceEndeavor Commerce, LLCK261134Dormiva Anti-Snoring Mouth GuardKoncept Innovators, Inc.K252942ShaeferHShaeferh, LLC

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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