510(k) K973548
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- March 23, 1998
- Date Received
- September 18, 1997
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Mercury
- Device Class
- Class II
- Regulation Number
- 872.3070
- Review Panel
- DE
- Submission Type