510(k) K080261
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 11, 2008
- Date Received
- February 1, 2008
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Manipulator, Plunger-Like Joint
- Device Class
- Class U
- Regulation Number
- Review Panel
- PM
- Submission Type