510(k) K890997
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 28, 1989
- Date Received
- February 27, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Resins, Ion-Exchange
- Device Class
- Class I
- Regulation Number
- 862.2230
- Review Panel
- TX
- Submission Type