The following data is part of a premarket notification filed by Angiomed U.s., Inc. with the FDA for Angiomed Osty-cut Bone Biopsy Needle.
| Device ID | K874585 |
| 510k Number | K874585 |
| Device Name: | ANGIOMED OSTY-CUT BONE BIOPSY NEEDLE |
| Classification | Needle, Biopsy, Cardiovascular |
| Applicant | ANGIOMED U.S., INC. 4081 EAST LA PALMA AVE., SUITE E Anaheim, CA 92807 |
| Contact | Michael Mccallum |
| Correspondent | Michael Mccallum ANGIOMED U.S., INC. 4081 EAST LA PALMA AVE., SUITE E Anaheim, CA 92807 |
| Product Code | DWO |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1987-11-09 |
| Decision Date | 1987-12-02 |