The following data is part of a premarket notification filed by Deroyal Industries, Inc. with the FDA for General Surgery Tray.
| Device ID | K842648 |
| 510k Number | K842648 |
| Device Name: | GENERAL SURGERY TRAY |
| Classification | General Surgery Tray |
| Applicant | DEROYAL INDUSTRIES, INC. Powell, TN 37849 |
| Contact | Sarah Bennett |
| Correspondent | Sarah Bennett DEROYAL INDUSTRIES, INC. Powell, TN 37849 |
| Product Code | LRO |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-08-13 |
| Decision Date | 1984-09-20 |