510(k) K953681
K953681 is an FDA 510(k) premarket notification submitted by Haemonetics Corp. for the device "HAEMONETICS THERAPEUTIC PLASMA EXCHANGE SET". The FDA issued a decision of Substantially Equivalent on June 4, 1996. The device falls under product code LKN (Separator, Automated, Blood Cell And Plasma, Therapeutic), a Class U device. Haemonetics Corp. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 4, 1996
- Date Received
- August 7, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Separator, Automated, Blood Cell And Plasma, Therapeutic
- Device Class
- Class U
- Regulation Number
- Review Panel
- GU
- Submission Type