510(k) DEN150002
- Device
- EarLens Contact Hearing Device
- Applicant
- Earlens Corporation
- 510(k) number
- DEN150002
- Product code
- PLK
- Decision
- Unknown (DENG)
- Decision date
- 2015-09-29
- Date received
- 2015-01-02
- Regulation
- 874.3315
- Classification name
- Tympanic Membrane Direct Contact Hearing Aid
- Medical specialty
- Ear, Nose, Throat
- Review panel
- Ear, Nose, Throat
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- SUZANNE LEVY
- Address
- 4045-A Cambbell Ave. Menlo Park CA US 94025 94025
FDA Registration Numbers#
- 3010863048
Source Documents#
510(k) summary PDF not indicated by FDA