The following data is part of a premarket notification filed by Radix Group Intl. with the FDA for Sunglasses Model #sp Promo #1 And Sp Promo #2.
| Device ID | K910597 |
| 510k Number | K910597 |
| Device Name: | SUNGLASSES MODEL #SP PROMO #1 AND SP PROMO #2 |
| Classification | Sunglasses (non-prescription Including Photosensitive) |
| Applicant | RADIX GROUP INTL. 129 NORTH HAMILTON RD. Columbus, OH 43213 |
| Contact | Jonna Barr |
| Correspondent | Jonna Barr RADIX GROUP INTL. 129 NORTH HAMILTON RD. Columbus, OH 43213 |
| Product Code | HQY |
| CFR Regulation Number | 886.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1991-02-12 |
| Decision Date | 1991-04-26 |