510(k) K093915
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 23, 2011
- Date Received
- December 22, 2009
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Clamp, Tubing, Blood, Automatic
- Device Class
- Class II
- Regulation Number
- 876.5820
- Review Panel
- GU
- Submission Type