510(k) K864983
K864983 is an FDA 510(k) premarket notification submitted by Cooper Lasersonics, Inc. for the device "CUSA SYSTEM 200 MACRO-DISSECTOR". The FDA issued a decision of Substantially Equivalent on June 23, 1987. The device falls under product code LFL (Instrument, Ultrasonic Surgical), a Class U device. Cooper Lasersonics, Inc. has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- June 23, 1987
- Date Received
- December 22, 1986
- 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