510(k) K760592
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 23, 1976
- Date Received
- September 7, 1976
- 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