510(k) K033268
K033268 is an FDA 510(k) premarket notification submitted by Sea-Band UK , Ltd. for the device "SEA-BAND". The FDA issued a decision of Substantially Equivalent on Jan 7, 2004. The device falls under product code MVV (Device, Acupressure), a Class U device.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Jan 7, 2004
- Date Received
- Oct 9, 2003
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device classification
- Device Name
- Device, Acupressure
- Device Class
- Class U
- Review Panel
- NE
- Submission Type
- Enforcement Discretion