The following data is part of a premarket notification filed by Debusk Technology Corp. with the FDA for Deroyal Industries, Inc. Neonatal Eye Cover.
| Device ID | K962290 |
| 510k Number | K962290 |
| Device Name: | DEROYAL INDUSTRIES, INC. NEONATAL EYE COVER |
| Classification | Pad, Neonatal Eye |
| Applicant | DEBUSK TECHNOLOGY CORP. 200 DEBUSK LN. Powell, TN 37849 |
| Contact | Camille Matlock |
| Correspondent | Camille Matlock DEBUSK TECHNOLOGY CORP. 200 DEBUSK LN. Powell, TN 37849 |
| Product Code | FOK |
| CFR Regulation Number | 880.5270 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-06-14 |
| Decision Date | 1996-07-03 |