Product code ESH— Ear, Nose, Throat
AUDI-SIL EARMOLD MATERIAL
- Classification name
- Polymer, Ent Synthetic-Pife, Silicon Elastomer, Polyethylene, Polyurethane
- Device class
- Class 2
- Regulation
- 21 CFR 874.3620
- Advisory panel
- Ear, Nose, Throat
- Total cleared
- 1
- First cleared
- Most recent
Market context for product code ESH
FDA has cleared device under product code ESH, all in 1977, filed by 1 applicant company. No FDA device recalls reference this product code. Class II devices are moderate-risk and subject to general and special controls; most reach market through 510(k) clearance by demonstrating substantial equivalence to a predicate device.
Top applicants under product code ESH
Recent clearances under product code ESH
Data sourced from openFDA. This site is unofficial and independent of the FDA.