510(k) K142339
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 26, 2014
- Date Received
- August 21, 2014
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Wax, Bone
- Device Class
- Class U
- Regulation Number
- Review Panel
- OR
- Submission Type