510(k) K110355
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 22, 2011
- Date Received
- February 7, 2011
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Stylet, Surgical, General & Plastic Surgery
- Device Class
- Class I
- Regulation Number
- 878.4800
- Review Panel
- SU
- Submission Type