K931389 is an FDA 510(k) clearance for the ITEM # 754 HOT FLIP SHADES. This device is classified as a Sunglasses (non-prescription Including Photosensitive) (Class I - General Controls, product code HQY).
Submitted by Ja-Ru, Inc. (Jacksonville, US). The FDA issued a Cleared decision on October 6, 1993, 202 days after receiving the submission on March 18, 1993.
This device falls under the Ophthalmic FDA review panel. Regulated under 21 CFR 886.5850.
| 510(k) Number | K931389 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | March 18, 1993 |
| Decision Date | October 06, 1993 |
| Days to Decision | 202 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 |