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FDA 510(k)

TUM-E-VAC BITE BLOCK

K-Number: K921946 · 1992-12-09

ApplicantEthox Corp.
Decision Date1992-12-09
Product CodeJXL
Advisory CommitteeNE
DecisionSubstantially Equivalent

Device Summary

TUM-E-VAC BITE BLOCK is the device name listed in this FDA 510(k) record. The listed applicant is Ethox Corp.. It received FDA 510(k) clearance on 1992-12-09 under 510(k) number K921946. The device is classified under product code JXL. It was reviewed by the NE advisory panel. FDA Decision: Substantially Equivalent.

Frequently Asked Questions

What is the TUM-E-VAC BITE BLOCK?

TUM-E-VAC BITE BLOCK is a medical device that received FDA 510(k) clearance on 1992-12-09. The listed applicant is Ethox Corp.. The 510(k) number is K921946.

When did TUM-E-VAC BITE BLOCK receive FDA 510(k) clearance?

TUM-E-VAC BITE BLOCK received FDA 510(k) clearance on 1992-12-09, under 510(k) number K921946.

Who is the listed applicant for TUM-E-VAC BITE BLOCK?

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

What is the FDA product code for TUM-E-VAC BITE BLOCK?

The FDA product code for TUM-E-VAC BITE BLOCK is JXL.

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Other records listing Ethox Corp. 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.

K040286ETHOX SURGI-CUF ADULT DISPOSABLE BLOOD PRESSURE CUFFSK031195CUF-COVER (TM)K962850TUM-E-VACK935633NO-MESK885220PERCUTANEOUS ENDOSCOPIC GASTROSTOMY KITK894927SURGI SQUEEZ

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Related Devices (Code: JXL)

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.

K221469PATI (Protector Against Tongue Injury)Neurovice, LLCK201309ECT Cotton Bite Block- size Large, ECT Cotton Bite Block -size MediumMecta CorporationK172978SurgeoBiteSurgovations, LLCK050188EPIGUARDEpisafe Medical Devices, Ltd.K992269VENTIL-A ORAL PROTECTORSomatics, Inc.K960663UNIVERSAL BITE BLOCKB&B Medical Technologies, Inc.

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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