510(k) K853663
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 9, 1986
- Date Received
- September 3, 1985
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Container, Frozen Donor Tissue Storage
- Device Class
- Class U
- Regulation Number
- Review Panel
- HO
- Submission Type