The following data is part of a premarket notification filed by Ursus Konsult Ab with the FDA for Trotex Ii Screw Needle Biopsy Instr. Set.
| Device ID | K792316 |
| 510k Number | K792316 |
| Device Name: | TROTEX II SCREW NEEDLE BIOPSY INSTR. SET |
| Classification | Brush, Biopsy, General & Plastic Surgery |
| Applicant | URSUS KONSULT AB 803 N. Front St. Suite 3 Mchenry, IL 60050 |
| Product Code | GEE |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1979-11-16 |
| Decision Date | 1979-12-18 |