510(k) DEN050007
- Device
- HEALTHCHECK(TM) HOME TEST FOR LOSS OF THE SENSE OF SMELL
- Applicant
- Fmg Innovations, Inc.
- 510(k) number
- DEN050007
- Product code
- NRK
- Decision
- Unknown (DENG)
- Decision date
- 2006-03-27
- Date received
- 2005-06-20
- Regulation
- 874.1600
- Classification name
- Kit, Test, Olfactory
- Medical specialty
- Ear, Nose, Throat
- Review panel
- Ear, Nose, Throat
- Device class
- 2
- Clearance type
- Post-NSE
- Third party reviewed
- N
Applicant Contact#
- Contact
- LINDA D BENTLEY
- Address
- One Financial Center Boston MA US 02111 02111
FDA Registration Numbers#
- 3007972833
- 3022472576
- 3017503380
- 3042838444
- 3042617034
- 3015259871
- 3027256314
Source Documents#
510(k) summary PDF not indicated by FDA