| Device Classification Name |
Needle, Aspiration And Injection, Disposable
|
| 510(k) Number |
K842106 |
| Device Name |
LEE BONE MARROW NEEDLES |
| Applicant |
| Southland Instruments, Inc. |
| P.O. Box 24288 |
|
Minneapolis,
MN
55424
|
|
| Applicant Contact |
PETER F LEE |
| Correspondent |
| Southland Instruments, Inc. |
| P.O. Box 24288 |
|
Minneapolis,
MN
55424
|
|
| Correspondent Contact |
PETER F LEE |
| Regulation Number | 878.4800 |
| Classification Product Code |
|
| Date Received | 05/25/1984 |
| Decision Date | 08/10/1984 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
General & Plastic Surgery
|
| 510k Review Panel |
General & Plastic Surgery
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|