510(k) K973506
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 27, 1998
- Date Received
- September 16, 1997
- 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