The following data is part of a premarket notification filed by Meadox Surgimed, Inc. with the FDA for Rotex Screw Biopsy Needle.
| Device ID | K854404 |
| 510k Number | K854404 |
| Device Name: | ROTEX SCREW BIOPSY NEEDLE |
| Classification | Biopsy Needle |
| Applicant | MEADOX SURGIMED, INC. 112 BAUER DR. Oakland, NJ 07436 |
| Contact | Scott Mindrebo |
| Correspondent | Scott Mindrebo MEADOX SURGIMED, INC. 112 BAUER DR. Oakland, NJ 07436 |
| Product Code | FCG |
| CFR Regulation Number | 876.1075 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-11-01 |
| Decision Date | 1985-12-02 |