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FDA 510(k)

SNORE-CURE ANTI-SNORING APPLIANCE

K-Number: K980952 · 1998-06-01

ApplicantORTHO-TAIN, Inc.
Decision Date1998-06-01
Product CodeLRK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

SNORE-CURE ANTI-SNORING APPLIANCE is the device name listed in this FDA 510(k) record. The listed applicant is ORTHO-TAIN, Inc.. It received FDA 510(k) clearance on 1998-06-01 under 510(k) number K980952. 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 SNORE-CURE ANTI-SNORING APPLIANCE?

SNORE-CURE ANTI-SNORING APPLIANCE is a medical device that received FDA 510(k) clearance on 1998-06-01. The listed applicant is ORTHO-TAIN, Inc.. The 510(k) number is K980952.

When did SNORE-CURE ANTI-SNORING APPLIANCE receive FDA 510(k) clearance?

SNORE-CURE ANTI-SNORING APPLIANCE received FDA 510(k) clearance on 1998-06-01, under 510(k) number K980952.

Who is the listed applicant for SNORE-CURE ANTI-SNORING APPLIANCE?

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

What is the FDA product code for SNORE-CURE ANTI-SNORING APPLIANCE?

The FDA product code for SNORE-CURE ANTI-SNORING 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 ORTHO-TAIN, 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.

K931615NITE-GUIDE

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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