WATER FILLED GUM SOOTHER— 510(k) K981202

Substantially Equivalent

Corium Corp.

FDA 510(k) clearance K981202 for WATER FILLED GUM SOOTHER, Substantially Equivalent on 1998-06-16. Applicant: Corium Corp.. Device class: 2.

Clearance details

Applicant: Corium Corp.
Product code: Code KKO
Device class: Class 2
Regulation: 21 CFR 872.5550
Advisory panel: Dental
Date received: 1998-04-02
Decision date: 1998-06-16
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Monroe, LA, US

Download summary PDF View on FDA.gov ↗

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K092781 — MAM TWISTER2010-06-23

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