The following data is part of a premarket notification filed by Deroyal Industries, Inc. with the FDA for Sterile,disposable Eye Dressing.
| Device ID | K921349 |
| 510k Number | K921349 |
| Device Name: | STERILE,DISPOSABLE EYE DRESSING |
| Classification | Pad, Eye |
| Applicant | DEROYAL INDUSTRIES, INC. 200 DEBUSK LN. Powell, TN 37849 |
| Contact | Debra Manning |
| Correspondent | Debra Manning DEROYAL INDUSTRIES, INC. 200 DEBUSK LN. Powell, TN 37849 |
| Product Code | HMP |
| CFR Regulation Number | 878.4440 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1992-03-19 |
| Decision Date | 1992-05-29 |