510(k) K162525
K162525 is an FDA 510(k) premarket notification submitted by Begum Saglik Hizmetleri Tibbi Malzemeler Danismanlik Lsti for the device "Oniko nail brace". The FDA issued a decision of Substantially Equivalent on April 25, 2018. The device falls under product code MQZ (Prosthesis, Nail), a Class U device.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- April 25, 2018
- Date Received
- September 9, 2016
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Prosthesis, Nail
- Device Class
- Class U
- Regulation Number
- Review Panel
- SU
- Submission Type