Device type

Ear, Nose, And Throat Surgical Tray

Product code OGR · Class I · 21 CFR 874.4420 · Ear, Nose, Throat

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

FDA classification database