The following data is part of a premarket notification filed by Ruff House, Inc. with the FDA for Ruff Work Eyegear.
| Device ID | K972717 |
| 510k Number | K972717 |
| Device Name: | RUFF WORK EYEGEAR |
| Classification | Sunglasses (non-prescription Including Photosensitive) |
| Applicant | RUFF HOUSE, INC. 136 COMMONWEALTH RD. Rochester, NY 14618 |
| Contact | Thomas C Ruff |
| Correspondent | Thomas C Ruff RUFF HOUSE, INC. 136 COMMONWEALTH RD. Rochester, NY 14618 |
| Product Code | HQY |
| CFR Regulation Number | 886.5850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-07-21 |
| Decision Date | 1997-08-25 |