The following data is part of a premarket notification filed by Marketing Innovations Intl., Inc. with the FDA for Plastic Frame & Lens Sunglass.
| Device ID | K881419 |
| 510k Number | K881419 |
| Device Name: | PLASTIC FRAME & LENS SUNGLASS |
| Classification | Sunglasses (non-prescription Including Photosensitive) |
| Applicant | MARKETING INNOVATIONS INTL., INC. 23901 CALABASAS RD. SUITE 1051 Calabasas, CA 91302 |
| Contact | James Smith |
| Correspondent | James Smith MARKETING INNOVATIONS INTL., INC. 23901 CALABASAS RD. SUITE 1051 Calabasas, CA 91302 |
| Product Code | HQY |
| CFR Regulation Number | 886.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1988-04-04 |
| Decision Date | 1988-05-25 |