510(k) K893733
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- July 20, 1989
- Date Received
- May 17, 1989
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Clinical Sample Concentrator
- Device Class
- Class I
- Regulation Number
- 862.2310
- Review Panel
- CH
- Submission Type