K962290 is an FDA 510(k) clearance for the DEROYAL INDUSTRIES, INC. NEONATAL EYE COVER. This device is classified as a Pad, Neonatal Eye (Class I - General Controls, product code FOK).
Submitted by Debusk Technology Corp. (Powell, US). The FDA issued a Cleared decision on July 3, 1996, 19 days after receiving the submission on June 14, 1996.
This device falls under the General Hospital FDA review panel. Regulated under 21 CFR 880.5270.
| 510(k) Number | K962290 FDA.gov |
| FDA Decision | Cleared Substantially Equivalent - Traditional 510(k) (SESE) |
| Date Received | June 14, 1996 |
| Decision Date | July 03, 1996 |
| Days to Decision | 19 days |
| Submission Type | Traditional |
| Review Panel | General Hospital (HO) |
| Summary | Summary PDF |
| Product Code | FOK — Pad, Neonatal Eye |
| Device Class | Class I - General Controls |
| CFR Regulation | 21 CFR 880.5270 |