The following data is part of a premarket notification filed by Mi Gwang Contact Lens Co., Ltd. with the FDA for Migwang Comfort 38 (polymacon) Spherical And Toric Soft Contact Lens For Daily Wear (clear, Tinted And Cosmetic).
| Device ID | K051477 |
| 510k Number | K051477 |
| Device Name: | MIGWANG COMFORT 38 (POLYMACON) SPHERICAL AND TORIC SOFT CONTACT LENS FOR DAILY WEAR (CLEAR, TINTED AND COSMETIC) |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | MI GWANG CONTACT LENS CO., LTD. 2214 SANFORD DRIVE B7 Grand Junction, CO 81505 |
| Contact | Martin Dalsing |
| Correspondent | Martin Dalsing MI GWANG CONTACT LENS CO., LTD. 2214 SANFORD DRIVE B7 Grand Junction, CO 81505 |
| Product Code | LPL |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2005-06-03 |
| Decision Date | 2006-03-10 |
| Summary: | summary |