510(k) K994320
- Device
- CHROMAGEN V2.0 HAPLOSCOPIC SYSTEM & COLOR VISION ENHANCEMENT SOFT CONTACT LENSES
- Applicant
- CANTOR & SILVER LTD.
- 510(k) number
- K994320
- Product code
- NCZ
- Decision
- Substantially Equivalent (SESE)
- Decision date
- 2000-10-20
- Date received
- 1999-12-22
- Regulation
- 886.5925
- Classification name
- Lens, Contact, For Color Vision Deficiency
- Medical specialty
- Ophthalmic
- Review panel
- Ophthalmic
- Device class
- 2
- Clearance type
- Traditional
- Statement or summary
- Summary
- Third party reviewed
- No
Applicant Contact#
- Contact
- MARTIN DALSING
- Address
- 623 Glacier Dr. Grand Junction CO US 81503 81503
FDA Registration Numbers#
- 9610790
Source Documents#
Legacy Summary#
summary
FDA Review#
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