510(k) K971565
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 12, 1998
- Date Received
- April 29, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Coagulator-Cutter, Endoscopic, Bipolar (And Accessories)
- Device Class
- Class II
- Regulation Number
- 884.4150
- Review Panel
- OB
- Submission Type