510(k) K003640
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- February 22, 2001
- Date Received
- November 27, 2000
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Scaler, Rotary
- Device Class
- Class II
- Regulation Number
- 872.4840
- Review Panel
- DE
- Submission Type