510(k) K022729
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- November 14, 2002
- Date Received
- August 16, 2002
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Instrument, Surgical, Sonic And Accessory/Attachment
- Device Class
- Class II
- Regulation Number
- 888.4580
- Review Panel
- OR
- Submission Type