510(k) K980804
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 1, 1998
- Date Received
- March 2, 1998
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Trocar, Gastro-Urology
- Device Class
- Class II
- Regulation Number
- 876.5090
- Review Panel
- SU
- Submission Type