KKY · Class II · 21 CFR 878.3500

FDA Product Code KKY: Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction

25
Total
25
Cleared
164d
Avg days
1978
Since
Stable submission activity - 0 submissions in the last 2 years

FDA 510(k) Cleared Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction Devices (Product Code KKY)

25 devices
1–24 of 25
No devices found for this product code.

About Product Code KKY - Regulatory Context

510(k) Submission Activity

25 total 510(k) submissions under product code KKY since 1978, with 25 receiving FDA clearance (average review time: 164 days).

Submission volume has remained relatively stable over the observed period, with 0 submissions in the last 24 months.