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FDA 510(k)

NOSE BREATHE MOUTHPIECE FOR HEAVY SNORER

K-Number: K013687 · 2002-05-28

ApplicantSteven K. Sue
Decision Date2002-05-28
Product CodeLRK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

NOSE BREATHE MOUTHPIECE FOR HEAVY SNORER is the device name listed in this FDA 510(k) record. The listed applicant is Steven K. Sue. It received FDA 510(k) clearance on 2002-05-28 under 510(k) number K013687. 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 NOSE BREATHE MOUTHPIECE FOR HEAVY SNORER?

NOSE BREATHE MOUTHPIECE FOR HEAVY SNORER is a medical device that received FDA 510(k) clearance on 2002-05-28. The listed applicant is Steven K. Sue. The 510(k) number is K013687.

When did NOSE BREATHE MOUTHPIECE FOR HEAVY SNORER receive FDA 510(k) clearance?

NOSE BREATHE MOUTHPIECE FOR HEAVY SNORER received FDA 510(k) clearance on 2002-05-28, under 510(k) number K013687.

Who is the listed applicant for NOSE BREATHE MOUTHPIECE FOR HEAVY SNORER?

The FDA 510(k) record lists Steven K. Sue as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NOSE BREATHE MOUTHPIECE FOR HEAVY SNORER?

The FDA product code for NOSE BREATHE MOUTHPIECE FOR HEAVY SNORER 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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