FLUID-FILLED TEETHER— 510(k) K092910

Name: FDA 510(k) clearance K092910
Creator: U.S. Food and Drug Administration
Published: 2009-12-18

Substantially Equivalent

Qualiman Industrial Co., Ltd.

FDA 510(k) clearance K092910 for FLUID-FILLED TEETHER, Substantially Equivalent on 2009-12-18. Applicant: Qualiman Industrial Co., Ltd.. Device class: 2.

Clearance details

Applicant: Qualiman Industrial Co., Ltd.
Product code: Code KKO
Device class: Class 2
Regulation: 21 CFR 872.5550
Advisory panel: Dental
Date received: 2009-09-22
Decision date: 2009-12-18
Decision: Substantially Equivalent
Clearance type: Traditional
Location: Greenwood Village, CO, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KKO

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K123855 — WATER-FILLED TEETHER2013-05-24
K110615 — WATER FILLED TEETHER, WATER FILLED TEETHER WITH HANDLE2011-12-02
K092025 — FLUID FILLED TEETHER - GEL2011-01-27
K093266 — MAM COOLER2010-07-27
K092781 — MAM TWISTER2010-06-23

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