510(k) K062544
K062544 is an FDA 510(k) premarket notification submitted by Arobella Medical, LLC for the device "AR1000 ULTRASONIC WOUND THERAPY SYSTEM". The FDA issued a decision of Substantially Equivalent on January 3, 2007. The device falls under product code LFL (Instrument, Ultrasonic Surgical), a Class U device. Arobella Medical, LLC has at least 2 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- January 3, 2007
- Date Received
- August 30, 2006
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Instrument, Ultrasonic Surgical
- Device Class
- Class U
- Regulation Number
- Review Panel
- SU
- Submission Type