ORAL PHARYNGEAL CLEANSING DEVICE— 510(k) K905011

Name: FDA 510(k) clearance K905011
Creator: U.S. Food and Drug Administration
Published: 1991-01-31

Substantially Equivalent

Concord/Portex

FDA 510(k) clearance K905011 for ORAL PHARYNGEAL CLEANSING DEVICE, Substantially Equivalent on 1991-01-31. Applicant: Concord/Portex. Device class: 1.

Clearance details

Applicant: Concord/Portex
Product code: Code EIA
Device class: Class 1
Regulation: 21 CFR 872.6640
Advisory panel: Dental
Date received: 1990-11-07
Decision date: 1991-01-31
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Keene, NH, 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.