FCE · Class I · 21 CFR 876.5210

FDA Product Code FCE: Enema Kit

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.

30
Total
30
Cleared
79d
Avg days
1976
Since

FDA 510(k) Cleared Enema Kit Devices (Product Code FCE)

30 devices
1–24 of 30
No devices found for this product code.

About Product Code FCE - Regulatory Context