Disclaimer: This site aggregates publicly available data from official government sources (FDA, ClinicalTrials.gov, PubMed, SEC EDGAR) for general reference only. It does NOT constitute medical advice, diagnosis, treatment recommendations, or investment advice.

FDA 510(k)

ADJUSTABLE SOFT PALATE LIFTER

K-Number: K895189 · 1990-02-09

ApplicantOrtho Publications, Inc.
Decision Date1990-02-09
Product CodeLRK
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ADJUSTABLE SOFT PALATE LIFTER is the device name listed in this FDA 510(k) record. The listed applicant is Ortho Publications, Inc.. It received FDA 510(k) clearance on 1990-02-09 under 510(k) number K895189. 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 ADJUSTABLE SOFT PALATE LIFTER?

ADJUSTABLE SOFT PALATE LIFTER is a medical device that received FDA 510(k) clearance on 1990-02-09. The listed applicant is Ortho Publications, Inc.. The 510(k) number is K895189.

When did ADJUSTABLE SOFT PALATE LIFTER receive FDA 510(k) clearance?

ADJUSTABLE SOFT PALATE LIFTER received FDA 510(k) clearance on 1990-02-09, under 510(k) number K895189.

Who is the listed applicant for ADJUSTABLE SOFT PALATE LIFTER?

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

What is the FDA product code for ADJUSTABLE SOFT PALATE LIFTER?

The FDA product code for ADJUSTABLE SOFT PALATE LIFTER 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 Publications, 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.

K874416DENTAL ANTI-SNORING DEVICE

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.

↑