The following data is part of a premarket notification filed by Radi Medical Systems Ab with the FDA for Bonopty Coaxial Bone Biopsy System With Eccentric Drill(10-1072,3,4).
| Device ID | K962425 |
| 510k Number | K962425 |
| Device Name: | BONOPTY COAXIAL BONE BIOPSY SYSTEM WITH ECCENTRIC DRILL(10-1072,3,4) |
| Classification | Needle, Aspiration And Injection, Disposable |
| Applicant | RADI MEDICAL SYSTEMS AB PALMBLADSGATAN 10 Uppsala, SE S-754 50 |
| Contact | Per Egnelov |
| Correspondent | Per Egnelov RADI MEDICAL SYSTEMS AB PALMBLADSGATAN 10 Uppsala, SE S-754 50 |
| Product Code | GAA |
| Subsequent Product Code | DWO |
| Subsequent Product Code | GDM |
| Subsequent Product Code | MJG |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1996-06-24 |
| Decision Date | 1996-09-11 |
| Summary: | summary |