510(k) K984219
- Device
- COLORMAX COLOR VISION ENHANCEMENT LENSES
- Applicant
- COLOR VISION TECHNOLOGIES, INC.
- 510(k) number
- K984219
- Product code
- NAI
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 1999-11-18
- Date received
- 1998-11-25
- Regulation
- 886.5844
- Classification name
- Lens, Prescription, Color Deficiency
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 1
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- JULIE KIM
- Address
- 19726 Colima Rd. Suite 320 Rowland Heights CA US 91748 91748
FDA Registration Numbers#
- 3008492653
- 3011660733
- 3010908619
- 3005890070
- 3004409566
- 3009455348
- 8043097
- 3043709869
- 3010119835
- 3009491490
- 3012376402
- 3027783184
- 3011248235
- 3003512352
Source Documents#
Legacy Summary#
summary
FDA Review#
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