510(k) K960144
K960144 is an FDA 510(k) premarket notification submitted by GE Medical Systems for the device "G.E. STERILE CT BIOPSY TRAY". The FDA issued a decision of Substantially Equivalent (kit) on April 15, 1996. The device falls under product code DWS (Instruments, Surgical, Cardiovascular), a Class I device regulated under 21 CFR 870.4500. GE Medical Systems has at least 10 other 510(k) clearances on record.
Clearance Details
- Decision
- SESK (Substantially Equivalent (kit))
- Decision Date
- April 15, 1996
- Date Received
- January 16, 1996
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Instruments, Surgical, Cardiovascular
- Device Class
- Class I
- Regulation Number
- 870.4500
- Review Panel
- CV
- Submission Type