K974511 is an FDA 510(k) clearance for the SUNGLASSES. This device is classified as a Sunglasses (non-prescription Including Photosensitive) (Class I - General Controls, product code HQY).
Submitted by Sun World Intl., Inc. (Franklin Square, US). The FDA issued a Cleared decision on January 12, 1998, 42 days after receiving the submission on December 1, 1997.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.5850.
| 510(k) Number | K974511 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | December 01, 1997 |
| Decision Date | January 12, 1998 |
| Days to Decision | 42 days |
| Submission Type | Traditional |
| Review Panel | Ophthalmic (OP) |
| Summary | Statement |
| Product Code | HQY — Sunglasses (non-prescription Including Photosensitive) |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 886.5850 |