MCZ · Class I · 21 CFR 878.4800

FDA Product Code MCZ: Suture Removal Kit

This Product Code Has Been Established In Accordance With The May 20, 1997, Guidance Entitled, Convenience Kits Interim Regulatory Guidance, Found At Http://www.fda.gov/downloads/medicaldevices/deviceregulationandguidance/guidancedocuments/ucm080217.pdf. 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.

15
Total
15
Cleared
137d
Avg days
1981
Since

FDA 510(k) Cleared Suture Removal Kit Devices (Product Code MCZ)

15 devices
1–15 of 15
No devices found for this product code.

About Product Code MCZ - Regulatory Context