510(k) K850803
K850803 is an FDA 510(k) premarket notification submitted by Inro Medical Designs, Inc. for the device "NAIL SPLINT". The FDA issued a decision of Substantially Equivalent on October 16, 1985. The device falls under product code MQZ (Prosthesis, Nail), a Class U device.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 16, 1985
- Date Received
- February 27, 1985
- 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