KAC · Class I · 21 CFR 874.4420

FDA Product Code KAC: Tube, Laryngectomy

Leading manufacturers include Shiley, Inc. and Portex, Inc..

4
Total
4
Cleared
80d
Avg days
1981
Since

FDA 510(k) Cleared Tube, Laryngectomy Devices (Product Code KAC)

4 devices
1–4 of 4
Cleared Mar 24, 1988
LARYNGECTOMY TUBE
K873992
Portex, Inc.
Ear, Nose, Throat · 175d
Cleared Aug 12, 1982
SHILEY LARYNGECTOMY TUBE
K821993
Shiley, Inc.
Ear, Nose, Throat · 36d

About Product Code KAC - Regulatory Context