inforMED
LROClass II

General Surgery Tray

General, Plastic Surgery · 21 CFR 878.4370

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 events20,596All time
Recalls1,045All time
Registered firms208Currently listed
510(k) clearances110All time

Recalls

1,045 recall events for this product code

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