510(k) K182054
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 29, 2018
- Date Received
- July 31, 2018
- Clearance Type
- Special
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Tissue Expander And Accessories
- Device Class
- Class U
- Regulation Number
- Review Panel
- SU
- Submission Type