The following data is part of a premarket notification filed by Marietta Contact Lens Service with the FDA for Marietta Contact Lens Service, Color Enhanced Tinted Soft Contact Lens.
| Device ID | K002647 |
| 510k Number | K002647 |
| Device Name: | MARIETTA CONTACT LENS SERVICE, COLOR ENHANCED TINTED SOFT CONTACT LENS |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | MARIETTA CONTACT LENS SERVICE 623 GLACIER DR. Grand Junction, CO 81503 |
| Contact | Martin Dalsing |
| Correspondent | Martin Dalsing MARIETTA CONTACT LENS SERVICE 623 GLACIER DR. Grand Junction, CO 81503 |
| Product Code | LPL |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2000-08-24 |
| Decision Date | 2000-09-13 |