510(k) K161483
K161483 is an FDA 510(k) premarket notification submitted by Stradis Healthcare for the device "Unger Quad Injector". The FDA issued a decision of Substantially Equivalent on October 31, 2016. The device falls under product code LCJ (Tissue Expander And Accessories), a Class U device.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 31, 2016
- Date Received
- May 31, 2016
- Clearance Type
- Traditional
- 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