The following data is part of a premarket notification filed by Simon Marketing, Inc. with the FDA for Out For Fun! Happy Meal Mcdonaldland Sunglasses.
| Device ID | K932018 |
| 510k Number | K932018 |
| Device Name: | OUT FOR FUN! HAPPY MEAL MCDONALDLAND SUNGLASSES |
| Classification | Sunglasses (non-prescription Including Photosensitive) |
| Applicant | SIMON MARKETING, INC. 1 TRANSAM PLAZA DR. SUITE 120 Oak Brook Terrace, IL 60181 |
| Contact | Kenneth Levin |
| Correspondent | Kenneth Levin SIMON MARKETING, INC. 1 TRANSAM PLAZA DR. SUITE 120 Oak Brook Terrace, IL 60181 |
| Product Code | HQY |
| CFR Regulation Number | 886.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1993-04-23 |
| Decision Date | 1993-08-10 |