510(k) K904469
K904469 is an FDA 510(k) premarket notification submitted by Kc Medical Industries for the device "EYEOPENER". The FDA issued a decision of Substantially Equivalent on June 28, 1991. The device falls under product code JYJ (Gauge, Measuring), a Class I device regulated under 21 CFR 874.4420.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 28, 1991
- Date Received
- October 1, 1990
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Gauge, Measuring
- Device Class
- Class I
- Regulation Number
- 874.4420
- Review Panel
- EN
- Submission Type