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FDA 510(k)

LABIAL CUSPID TUBE

K-Number: K834392 · 1984-02-28

ApplicantAlexotek Co.
Decision Date1984-02-28
Product CodeDZD
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

LABIAL CUSPID TUBE is the device name listed in this FDA 510(k) record. The listed applicant is Alexotek Co.. It received FDA 510(k) clearance on 1984-02-28 under 510(k) number K834392. The device is classified under product code DZD. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the LABIAL CUSPID TUBE?

LABIAL CUSPID TUBE is a medical device that received FDA 510(k) clearance on 1984-02-28. The listed applicant is Alexotek Co.. The 510(k) number is K834392.

When did LABIAL CUSPID TUBE receive FDA 510(k) clearance?

LABIAL CUSPID TUBE received FDA 510(k) clearance on 1984-02-28, under 510(k) number K834392.

Who is the listed applicant for LABIAL CUSPID TUBE?

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

What is the FDA product code for LABIAL CUSPID TUBE?

The FDA product code for LABIAL CUSPID TUBE is DZD.

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 Alexotek Co. 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.

K881789MINILINE BRACKETK834446ALEXOTEK LINGUAL TUBESK834272ALEXOLOK BRACKET

Related Devices (Code: DZD)

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.

K943421ORTHODONITC ELASTOMERIC SLEEVINGJon-Ko Products, Inc.K936243REGENCY TUBEOrtho SpecialtiesK935143DENTAURUM STAINLESS STEEL TUBINGDentauraum, Inc.K911399NASAL CPAP (CONTINUOUS POSITIVE AIR PRESSURE SYST)Aequitron Medical, Inc.K896586RATE INCREASE FOR IPPB/IPVPercussionaire Corp.K834446ALEXOTEK LINGUAL TUBESAlexotek Co.

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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