The following data is part of a premarket notification filed by Meadox Surgimed, Inc. with the FDA for Meadox Surgimed A/s Three Piece Screw Biopsy Needl.
| Device ID | K854420 |
| 510k Number | K854420 |
| Device Name: | MEADOX SURGIMED A/S THREE PIECE SCREW BIOPSY NEEDL |
| Classification | Needle, Aspiration And Injection, Reusable |
| Applicant | MEADOX SURGIMED, INC. 112 BAUER DR. Oakland, NJ 07436 |
| Contact | Scott J Mindrebo |
| Correspondent | Scott J Mindrebo MEADOX SURGIMED, INC. 112 BAUER DR. Oakland, NJ 07436 |
| Product Code | GDM |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1985-11-04 |
| Decision Date | 1985-11-22 |