MLS · Class II · 21 CFR 884.4530

FDA Product Code MLS: Labor And Delivery 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

6
Total
6
Cleared
193d
Avg days
1994
Since

FDA 510(k) Cleared Labor And Delivery Kit Devices (Product Code MLS)

6 devices
1–6 of 6
No devices found for this product code.

About Product Code MLS - Regulatory Context