GEL FILLED GUM SOOTHER— 510(k) K092494

Substantially Equivalent

Luv N' Care, Ltd.

FDA 510(k) clearance K092494 for GEL FILLED GUM SOOTHER, Substantially Equivalent on 2010-03-01. Applicant: Luv N' Care, Ltd.. Device class: 2.

Clearance details

Applicant: Luv N' Care, Ltd.
Product code: Code KKO
Device class: Class 2
Regulation: 21 CFR 872.5550
Advisory panel: Dental
Date received: 2009-08-14
Decision date: 2010-03-01
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Monroe, LA, 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.