510(k) K771615
- Device
- AUDI-SIL EARMOLD MATERIAL
- Applicant
- Coe Laboratories, Inc.
- 510(k) number
- K771615
- Product code
- ESH
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1977-08-30
- Date received
- 1977-08-24
- Regulation
- 874.3620
- Classification name
- Polymer, Ent Synthetic-Pife, Silicon Elastomer, Polyethylene, Polyurethane
- Medical specialty
- Ear, Nose, Throat
- Review panel
- Ear, Nose, Throat
- Device class
- 2
- Clearance type
- Traditional
- Third party reviewed
- N
Related Records
Applicant Contact
- Address
- 803 N. Front St. Suite 3 Mchenry IL US 60050 60050
Source Documents
510(k) summary PDF not indicated by FDA