OJU · Class I · 21 CFR 878.4800

FDA Product Code OJU: Skin Prep Tray

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

1
Total
1
Cleared
16d
Avg days
1978
Since

FDA 510(k) Cleared Skin Prep Tray Devices (Product Code OJU)

1 devices
1–1 of 1
No devices found for this product code.

About Product Code OJU - Regulatory Context