510(k) K994021
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 22, 2000
- Date Received
- November 26, 1999
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Accessories, Solution, Ultrasonic Cleaners For Lenses
- Device Class
- Class II
- Regulation Number
- 886.5928
- Review Panel
- OP
- Submission Type