510(k) K960843
K960843 is an FDA 510(k) premarket notification submitted by European Touch Co., Inc. for the device "STOP-N-GROW". The FDA issued a decision of Substantially Equivalent on August 12, 1996. The device falls under product code MQZ (Prosthesis, Nail), a Class U device.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- August 12, 1996
- Date Received
- February 29, 1996
- 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