510(k) K895881
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 10, 1990
- Date Received
- October 5, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Column, Adsorption, Low Density, Lipoprotein
- Device Class
- Class III
- Regulation Number
- Review Panel
- GU
- Submission Type