The following data is part of a premarket notification filed by Lem Srl. with the FDA for Lem Sunglasses & Frames Diff. Colors And Designs.
| Device ID | K870219 |
| 510k Number | K870219 |
| Device Name: | LEM SUNGLASSES & FRAMES DIFF. COLORS AND DESIGNS |
| Classification | Sunglasses (non-prescription Including Photosensitive) |
| Applicant | LEM SRL. VIA ROMA, 57 21020 DAVERIO (VARESE) Italy, IT |
| Contact | Giulio Borlin |
| Correspondent | Giulio Borlin LEM SRL. VIA ROMA, 57 21020 DAVERIO (VARESE) Italy, IT |
| Product Code | HQY |
| CFR Regulation Number | 886.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-01-21 |
| Decision Date | 1987-04-16 |