ESH · Class II · 21 CFR 874.3620

FDA Product Code ESH: Polymer, Ent Synthetic-pife, Silicon Elastomer, Polyethylene, Polyurethane

Leading manufacturers include Coe Laboratories, Inc..

1
Total
1
Cleared
6d
Avg days
1977
Since

FDA 510(k) Cleared Polymer, Ent Synthetic-pife, Silicon Elastomer, Polyethylene, Polyurethane Devices (Product Code ESH)

1 devices
1–1 of 1
Cleared Aug 30, 1977
AUDI-SIL EARMOLD MATERIAL
K771615
Coe Laboratories, Inc.
Ear, Nose, Throat · 6d

About Product Code ESH - Regulatory Context