The following data is part of a premarket notification filed by I-promotions, Inc. with the FDA for I-promotions Contact Lens Case.
| Device ID | K042578 |
| 510k Number | K042578 |
| Device Name: | I-PROMOTIONS CONTACT LENS CASE |
| Classification | Case, Contact Lens |
| Applicant | I-PROMOTIONS, INC. 9522 GRAVOIS RD. St. Louis, MO 63123 |
| Contact | Charlotte Slankard |
| Correspondent | Charlotte Slankard I-PROMOTIONS, INC. 9522 GRAVOIS RD. St. Louis, MO 63123 |
| Product Code | LRX |
| CFR Regulation Number | 886.5928 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 2004-09-22 |
| Decision Date | 2005-01-25 |
| Summary: | summary |