510(k) K955921
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 16, 1996
- Date Received
- December 14, 1995
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Cells, Animal And Human, Cultured
- Device Class
- Class I
- Regulation Number
- 864.2280
- Review Panel
- PA
- Submission Type