510(k) K760952
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 17, 1977
- Date Received
- November 2, 1976
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Container, Empty, For Collection & Processing Of Blood & Blood Components
- Device Class
- Class II
- Regulation Number
- 864.9100
- Review Panel
- HE
- Submission Type