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FDA 510(k)

ARK TONGUE CLEANER

K-Number: K844291 · 1984-11-23

ApplicantArkay Co.
Decision Date1984-11-23
Product CodeLCN
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

ARK TONGUE CLEANER is the device name listed in this FDA 510(k) record. The listed applicant is Arkay Co.. It received FDA 510(k) clearance on 1984-11-23 under 510(k) number K844291. The device is classified under product code LCN. It was reviewed by the DE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the ARK TONGUE CLEANER?

ARK TONGUE CLEANER is a medical device that received FDA 510(k) clearance on 1984-11-23. The listed applicant is Arkay Co.. The 510(k) number is K844291.

When did ARK TONGUE CLEANER receive FDA 510(k) clearance?

ARK TONGUE CLEANER received FDA 510(k) clearance on 1984-11-23, under 510(k) number K844291.

Who is the listed applicant for ARK TONGUE CLEANER?

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

What is the FDA product code for ARK TONGUE CLEANER?

The FDA product code for ARK TONGUE CLEANER is LCN.

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 Arkay 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.

K841077ARK TONGUE CLEANER

Related Devices (Code: LCN)

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.

K992270MIRACLEBREATH TONGUE CLEANERStellar Labs, Inc.K990344ORALGIENE TONGUE CLEANEROralgiene USA, Inc.K983683UNIK TONGUE CLEANERUnik Products, Inc.K983087BREATHTIQUE TONGUE SCRAPERCustom Medical Arts, Inc.K981808BREATHAID TONGUE SCRAPERBreathaid, LLCK980842COPPER TONGUE SCRAPEROntel Products Corp.

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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