510(k) K843219
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 29, 1984
- Date Received
- August 15, 1984
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Mixer, Cement, For Clinical Use
- Device Class
- Class I
- Regulation Number
- 888.4210
- Review Panel
- OR
- Submission Type