510(k) K831423
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 3, 1984
- Date Received
- May 3, 1983
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Columns, Immunoadsorption In Extracorporeal Systems
- Device Class
- Class III
- Regulation Number
- Review Panel
- GU
- Submission Type