510(k) K053464
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 6, 2006
- Date Received
- December 13, 2005
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Apparatus, Exhaust, Surgical
- Device Class
- Class II
- Regulation Number
- 878.5070
- Review Panel
- HO
- Submission Type