The following data is part of a premarket notification filed by Cantor & Silver Ltd. with the FDA for Chromagen V2.0 Haploscopic System & Color Vision Enhancement Soft Contact Lenses.
| Device ID | K994320 |
| 510k Number | K994320 |
| Device Name: | CHROMAGEN V2.0 HAPLOSCOPIC SYSTEM & COLOR VISION ENHANCEMENT SOFT CONTACT LENSES |
| Classification | Lens, Contact, For Color Vision Deficiency |
| Applicant | CANTOR & SILVER LTD. 623 GLACIER DR. Grand Junction, CO 81503 |
| Contact | Martin Dalsing |
| Correspondent | Martin Dalsing CANTOR & SILVER LTD. 623 GLACIER DR. Grand Junction, CO 81503 |
| Product Code | NCZ |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1999-12-22 |
| Decision Date | 2000-10-20 |
| Summary: | summary |