The following data is part of a premarket notification filed by Trinity Laboratories, Inc. with the FDA for Eye Tray.
| Device ID | K970722 |
| 510k Number | K970722 |
| Device Name: | EYE TRAY |
| Classification | Drape, Surgical |
| Applicant | TRINITY LABORATORIES, INC. 201 KILEY DR. P.O. BOX 1818 Salisbury, MD 21802 |
| Contact | Partha Basumallik |
| Correspondent | Partha Basumallik TRINITY LABORATORIES, INC. 201 KILEY DR. P.O. BOX 1818 Salisbury, MD 21802 |
| Product Code | KKX |
| Subsequent Product Code | HNM |
| Subsequent Product Code | HNN |
| Subsequent Product Code | HOY |
| CFR Regulation Number | 878.4370 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1997-02-27 |
| Decision Date | 1997-03-31 |