510(k) K792316
K792316 is an FDA 510(k) premarket notification submitted by Ursus Konsult AB for the device "TROTEX II SCREW NEEDLE BIOPSY INSTR. SET". The FDA issued a decision of Substantially Equivalent on December 18, 1979. The device falls under product code GEE (Brush, Biopsy, General & Plastic Surgery), a Class I device regulated under 21 CFR 878.4800.
Clearance Details
- Decision
- SESE (Substantially Equivalent)
- Decision Date
- December 18, 1979
- Date Received
- November 16, 1979
- Clearance Type
- Traditional
- Expedited Review
- No
- Third Party Review
- No
Device Classification
- Device Name
- Brush, Biopsy, General & Plastic Surgery
- Device Class
- Class I
- Regulation Number
- 878.4800
- Review Panel
- SU
- Submission Type