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 |