The following data is part of a premarket notification filed by Deroyal Industries, Inc. with the FDA for Tpn/hyperalimentation Tray.
| Device ID | K842644 |
| 510k Number | K842644 |
| Device Name: | TPN/HYPERALIMENTATION TRAY |
| Classification | Wrap, Sterilization |
| 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 | FRG |
| CFR Regulation Number | 880.6850 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-07-10 |
| Decision Date | 1984-11-08 |