TUM-E-VAC BITE BLOCK— 510(k) K921946

Substantially Equivalent

Ethox Corp.

FDA 510(k) clearance K921946 for TUM-E-VAC BITE BLOCK, Substantially Equivalent on 1992-12-09. Applicant: Ethox Corp.. Device class: 2.

Clearance details

Applicant: Ethox Corp.
Product code: Code JXL
Device class: Class 2
Regulation: 21 CFR 882.5070
Advisory panel: Neurology
Date received: 1992-04-27
Decision date: 1992-12-09
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Buffalo, NY, US

Download summary PDF View on FDA.gov ↗

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Data sourced from openFDA. This site is unofficial and independent of the FDA.