510(k) K082218
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 13, 2008
- Date Received
- August 6, 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