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)

OOLI-U(TONGUE SCRAPER)

K-Number: K970042 · 1997-03-14

ApplicantTelefax Intl.
Decision Date1997-03-14
Product CodeLCN
Advisory CommitteeDE
DecisionSubstantially Equivalent

Device Summary

OOLI-U(TONGUE SCRAPER) is the device name listed in this FDA 510(k) record. The listed applicant is Telefax Intl.. It received FDA 510(k) clearance on 1997-03-14 under 510(k) number K970042. 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 OOLI-U(TONGUE SCRAPER)?

OOLI-U(TONGUE SCRAPER) is a medical device that received FDA 510(k) clearance on 1997-03-14. The listed applicant is Telefax Intl.. The 510(k) number is K970042.

When did OOLI-U(TONGUE SCRAPER) receive FDA 510(k) clearance?

OOLI-U(TONGUE SCRAPER) received FDA 510(k) clearance on 1997-03-14, under 510(k) number K970042.

Who is the listed applicant for OOLI-U(TONGUE SCRAPER)?

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

What is the FDA product code for OOLI-U(TONGUE SCRAPER)?

The FDA product code for OOLI-U(TONGUE SCRAPER) 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

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

View on FDA Database →

Data sourced from FDA Open API. For the most current and authoritative information, always refer to the official record.

↑