ESF · Class II · 21 CFR 878.3500

FDA Product Code ESF: Polymer, Composite Synthetic Ptfe With Carbon-fiber, Ent

Leading manufacturers include Xomed, Inc. and Siemens Hearing Instruments, Inc..

2
Total
2
Cleared
92d
Avg days
1982
Since

FDA 510(k) Cleared Polymer, Composite Synthetic Ptfe With Carbon-fiber, Ent Devices (Product Code ESF)

2 devices
1–2 of 2
Cleared Mar 29, 1989
BEHIND-THE-EAR HEARING AID MODEL 404 PP-PC
K891247
Siemens Hearing Instruments, Inc.
General & Plastic Surgery · 21d
Cleared Apr 21, 1982
CERAVITAL CERAMIC EAR CANAL WALL PROSTH
K813224
Xomed, Inc.
General & Plastic Surgery · 163d

About Product Code ESF - Regulatory Context