510(k) K032424
K032424 is an FDA 510(k) premarket notification submitted by Sra Developments, Ltd. for the device "LOTUS". The FDA issued a decision of Substantially Equivalent on December 16, 2003. The device falls under product code LFL (Instrument, Ultrasonic Surgical), a Class U device. Sra Developments, Ltd. has at least 4 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 16, 2003
- Date Received
- August 5, 2003
- 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