Kit, Earmold, Impression

FDA product code LDG · Class I (low risk) · 21 CFR 874.3300 · Ear, Nose, Throat

2510(k) clearances
0PMA approvals
0recalls

Manufacturers

510(k) clearances

510(k)DeviceApplicantDecision
K823921Physicians Choice Silicone Ear PuttyLDG · Traditional Santa Barbara Medco, Inc.03/28/1983SE
K792428Coe-SilLDG · Traditional Coe Laboratories, Inc.01/23/1980SE