510(k) K183468

Revive Reusable Bladder Support by Rinovum Subsidiary 2, LLC — Product Code HHW

K183468 is an FDA 510(k) premarket notification submitted by Rinovum Subsidiary 2, LLC for the device "Revive Reusable Bladder Support". The FDA issued a decision of Substantially Equivalent on January 25, 2019. The device falls under product code HHW (Pessary, Vaginal), a Class II device regulated under 21 CFR 884.3575.