510(k) K010184
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 22, 2001
- Date Received
- January 19, 2001
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Instrument, Manual, Surgical, General Use
- Device Class
- Class I
- Regulation Number
- 878.4800
- Review Panel
- SU
- Submission Type