510(k) K211959

Milli Vaginal Dilator by Materna Medical — Product Code HDX

K211959 is an FDA 510(k) premarket notification submitted by Materna Medical for the device "Milli Vaginal Dilator". The FDA issued a decision of Substantially Equivalent on December 1, 2021. The device falls under product code HDX (Dilator, Vaginal), a Class II device regulated under 21 CFR 884.3900. Materna Medical has at least 1 other 510(k) clearance on record.