The following data is part of a premarket notification filed by Southland Instruments, Inc. with the FDA for Lee Bone Marrow Needles.
| Device ID | K842106 |
| 510k Number | K842106 |
| Device Name: | LEE BONE MARROW NEEDLES |
| Classification | Needle, Aspiration And Injection, Disposable |
| Applicant | SOUTHLAND INSTRUMENTS, INC. P.O. BOX 24288 Minneapolis, MN 55424 |
| Contact | Peter F Lee |
| Correspondent | Peter F Lee SOUTHLAND INSTRUMENTS, INC. P.O. BOX 24288 Minneapolis, MN 55424 |
| Product Code | GAA |
| CFR Regulation Number | 878.4800 [🔎] |
| Decision | Substantially Equivalent (SESE) |
| Type | Traditional |
| 3rd Party Reviewed | No |
| Combination Product | No |
| Date Received | 1984-05-25 |
| Decision Date | 1984-08-10 |