510(k) K884660
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 16, 1989
- Date Received
- November 7, 1988
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cleaner, Ultrasonic, Medical Instrument
- Device Class
- Class I
- Regulation Number
- 880.6150
- Review Panel
- HO
- Submission Type