510(k) K893829
K893829 is an FDA 510(k) premarket notification submitted by Sacks Model Makers for the device "POWERED EYE WASH". The FDA issued a decision of Substantially Equivalent on November 14, 1989. The device falls under product code MSI (Solution, Cleaning / Lubricating, Artificial Eye), a Class III device.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 14, 1989
- Date Received
- May 24, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Solution, Cleaning / Lubricating, Artificial Eye
- Device Class
- Class III
- Regulation Number
- Review Panel
- OP
- Submission Type