510(k) K042277
K042277 is an FDA 510(k) premarket notification submitted by Integra Neurosciences, Ltd. for the device "SELECTOR QUANTUM ULTRASONIC ASPIRATOR SYSTEM". The FDA issued a decision of Substantially Equivalent on September 29, 2004. The device falls under product code LFL (Instrument, Ultrasonic Surgical), a Class U device. Integra Neurosciences, Ltd. has at least 8 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- September 29, 2004
- Date Received
- August 23, 2004
- 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