510(k) DEN200002
- Device
- Tangible Boost
- Applicant
- Tangible Science, Inc.
- 510(k) number
- DEN200002
- Product code
- QMM
- Decision
- Unknown (DENG)
- Decision date
- 2020-09-24
- Date received
- 2020-01-13
- Regulation
- 886.5919
- Classification name
- Hydrophilic Re-Coating Solution
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 2
- Clearance type
- Direct
- Third party reviewed
- N
Applicant Contact#
- Contact
- Kelly Mabry
- Address
- 740 Broadway Redwood City CA US 94063 94063
FDA Registration Numbers#
- 3012862899
Source Documents#
510(k) summary PDF not indicated by FDA