The following data is part of a premarket notification filed by Australian Optical Co., Inc. with the FDA for Sunglass Clip.
| Device ID | K943640 |
| 510k Number | K943640 |
| Device Name: | SUNGLASS CLIP |
| Classification | Sunglasses (non-prescription Including Photosensitive) |
| Applicant | AUSTRALIAN OPTICAL CO., INC. 1775 UNIVERSAL AVE. SUITE 1620 Kansas City, MO 64120 |
| Contact | Shari Downing |
| Correspondent | Shari Downing AUSTRALIAN OPTICAL CO., INC. 1775 UNIVERSAL AVE. SUITE 1620 Kansas City, MO 64120 |
| Product Code | HQY |
| CFR Regulation Number | 886.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1994-07-27 |
| Decision Date | 1994-09-14 |