510(k) K820447
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 14, 1982
- Date Received
- February 18, 1982
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Set, Transfer (Blood/Plasma)
- Device Class
- Class II
- Regulation Number
- 864.9875
- Review Panel
- HE
- Submission Type