The following data is part of a premarket notification filed by Menicon Co. Ltd. with the FDA for One Day Flat Pack.
| Device ID | K102895 |
| 510k Number | K102895 |
| Device Name: | ONE DAY FLAT PACK |
| Classification | Lenses, Soft Contact, Daily Wear |
| Applicant | MENICON CO. LTD. 806 KIMBALL AVENUE Grand Junction, CO 81501 |
| Contact | Martin Dalsing |
| Correspondent | Martin Dalsing MENICON CO. LTD. 806 KIMBALL AVENUE Grand Junction, CO 81501 |
| Product Code | LPL |
| CFR Regulation Number | 886.5925 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2010-09-30 |
| Decision Date | 2011-04-28 |
| Summary: | summary |