510(k) K012298
- Device
- THE INTUITIVE COLORIMETER
- Applicant
- Cerium Optical Technologies, Inc.
- 510(k) number
- K012298
- Product code
- NFD
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2001-09-26
- Date received
- 2001-07-20
- Regulation
- 886.1160
- Classification name
- Selector, Color, Spectacle, Lens, Tint
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- N
Applicant Contact#
- Contact
- SOL AISENBERG
- Address
- 36 Bradford Rd. Natick MA US 01760 01760
FDA Registration Numbers#
- 3017774717
- 9614310
- 9680369
- 9616922
- 3012110814
- 3003488848
- 3010170531
- 3013318407
- 9681443