510(k) K962290
K962290 is an FDA 510(k) premarket notification submitted by Debusk Technology Corp. for the device "DEROYAL INDUSTRIES, INC. NEONATAL EYE COVER". The FDA issued a decision of Substantially Equivalent on July 3, 1996. The device falls under product code FOK (Pad, Neonatal Eye), a Class I device regulated under 21 CFR 880.5270. Debusk Technology Corp. has at least 3 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 3, 1996
- Date Received
- June 14, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Pad, Neonatal Eye
- Device Class
- Class I
- Regulation Number
- 880.5270
- Review Panel
- HO
- Submission Type