510(k) K900588
K900588 is an FDA 510(k) premarket notification submitted by Euro-Am Pharma, Inc. for the device "ACU-BAND ACCUPRESSURE WRIST BAND". The FDA issued a decision of Substantially Equivalent on Feb 22, 1990. The device falls under product code MVV (Device, Acupressure), a Class U device. Euro-Am Pharma, Inc. has 1 other 510(k) clearance on record.
Clearance details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- Feb 22, 1990
- Date Received
- Feb 7, 1990
- 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