510(k) K031523
K031523 is an FDA 510(k) premarket notification submitted by Aomori Olympus Co., Ltd. for the device "OLYMPUS ULTRASONIC SURGICAL SYSTEM". The FDA issued a decision of Substantially Equivalent on October 1, 2003. The device falls under product code LFL (Instrument, Ultrasonic Surgical), a Class U device. Aomori Olympus Co., Ltd. has at least 6 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- October 1, 2003
- Date Received
- May 15, 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