OGQClass I

Ear Irrigation Kit

General Hospital · 21 CFR 880.6960

This product code has been established in accordance with the may 20, 1997, guidance entitled, convenience kits interim regulatory guidance, found at www.Fda.Gov/cdrh/ode/convkit.Html. This type of convenience kit, as listed in the guidance above, is under enforcement discretion, and does not require a premarket notification (510(k)) to market if it meets all criteria in the guidance

MDR events10All time

Recalls0All time

Registered firms34Currently listed

510(k) clearances0All time