The following data is part of a premarket notification filed by Cantor & Nissel Ltd. with the FDA for Chromagen V3.0 Reading Aid Soft Contact Lens.
| Device ID | K012132 |
| 510k Number | K012132 |
| Device Name: | CHROMAGEN V3.0 READING AID SOFT CONTACT LENS |
| Classification | Lens, Contact, For Reading Discomfort |
| Applicant | CANTOR & NISSEL LTD. 623 GLACIER DR. Grand Juction, CO 81503 |
| Contact | Martin Dalsing |
| Correspondent | Martin Dalsing CANTOR & NISSEL LTD. 623 GLACIER DR. Grand Juction, CO 81503 |
| Product Code | NIC |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2001-07-09 |
| Decision Date | 2002-05-09 |
| Summary: | summary |