MAM TWISTER— 510(k) K092781

Substantially Equivalent

Mam International AG

FDA 510(k) clearance K092781 for MAM TWISTER, Substantially Equivalent on 2010-06-23. Applicant: Mam International AG. Device class: 2.

Clearance details

Applicant: Mam International AG
Product code: Code KKO
Device class: Class 2
Regulation: 21 CFR 872.5550
Advisory panel: Dental
Date received: 2009-09-10
Decision date: 2010-06-23
Decision: Substantially Equivalent
Clearance type: Traditional
Location: White Plains, NY, US

Download summary PDF View on FDA.gov ↗

Recent devices under product code KKO

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
K092494 — GEL FILLED GUM SOOTHER2010-03-01

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