MLT · Class II · 21 CFR 884.4530

FDA Product Code MLT: Pelvic Exam 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 Kit, As Described In The Guidance Above, Is Under Enforcement Discretion, And Does Not Require A Premarket Notification (510(k)) To Market.

1
Total
1
Cleared
333d
Avg days
1994
Since

FDA 510(k) Cleared Pelvic Exam Kit Devices (Product Code MLT)

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

About Product Code MLT - Regulatory Context