The following data is part of a premarket notification filed by Deroyal Industries, Inc. with the FDA for Cataract Tray.
| Device ID | K842647 |
| 510k Number | K842647 |
| Device Name: | CATARACT TRAY |
| Classification | Knife, Ophthalmic |
| Applicant | DEROYAL INDUSTRIES, INC. 200 DEBUSK LN. Powell, TN 37849 |
| Contact | Susan Hevey |
| Correspondent | Susan Hevey DEROYAL INDUSTRIES, INC. 200 DEBUSK LN. Powell, TN 37849 |
| Product Code | HNN |
| CFR Regulation Number | 886.4350 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-07-10 |
| Decision Date | 1985-05-09 |