510(k) K103302
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 18, 2011
- Date Received
- November 9, 2010
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Media, Culture, Ex Vivo, Tissue And Cell
- Device Class
- Class II
- Regulation Number
- 876.5885
- Review Panel
- GU
- Submission Type