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FDA 510(k)

NORAD, NOCTURNAL ORAL AIRWAY DILATOR APPLIANCE

K-Number: K013049 · 2001-11-29

ApplicantDennis R. Bailey, Dds
Decision Date2001-11-29
Product CodeLRK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

NORAD, NOCTURNAL ORAL AIRWAY DILATOR APPLIANCE is the device name listed in this FDA 510(k) record. The listed applicant is Dennis R. Bailey, Dds. It received FDA 510(k) clearance on 2001-11-29 under 510(k) number K013049. 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 NORAD, NOCTURNAL ORAL AIRWAY DILATOR APPLIANCE?

NORAD, NOCTURNAL ORAL AIRWAY DILATOR APPLIANCE is a medical device that received FDA 510(k) clearance on 2001-11-29. The listed applicant is Dennis R. Bailey, Dds. The 510(k) number is K013049.

When did NORAD, NOCTURNAL ORAL AIRWAY DILATOR APPLIANCE receive FDA 510(k) clearance?

NORAD, NOCTURNAL ORAL AIRWAY DILATOR APPLIANCE received FDA 510(k) clearance on 2001-11-29, under 510(k) number K013049.

Who is the listed applicant for NORAD, NOCTURNAL ORAL AIRWAY DILATOR APPLIANCE?

The FDA 510(k) record lists Dennis R. Bailey, Dds as the applicant. This does not by itself establish the device manufacturer.

What is the FDA product code for NORAD, NOCTURNAL ORAL AIRWAY DILATOR APPLIANCE?

The FDA product code for NORAD, NOCTURNAL ORAL AIRWAY DILATOR APPLIANCE is LRK.

Related Clinical Trials

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.

NCT07608549FLASH Pilot Phase 1 Safety StudyNOT_YET_RECRUITINGNCT06562205PAP Systems External Clinical Studies (ECS)NOT_YET_RECRUITINGNCT06443177The Effect of Sympathetic Modulation on Cerebral Vasospasm Secondary to Aneurysmal Subarachnoid HemorrhageSUSPENDEDNCT07095751Artificial Intelligence-assisted Uro-Cam Catheter Assessment System for Diagnosing Bladder CancerNOT_YET_RECRUITING

Other records listing Dennis R. Bailey, Dds 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.

K020893NORAD NOCTURNAL ORAL AIRWAY DILATOR APPLIANCE

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

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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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