| Device Classification Name |
Needle, Hypodermic, Single Lumen
|
| 510(k) Number |
K972536 |
| Device Name |
SYRINGE NEEDLE REMOVER (S.N.R.) |
| Applicant |
| Post Medical, Inc. |
| P.O. Box 29863 |
|
Atlanta,
GA
30359
|
|
| Applicant Contact |
DAVID R THEAD |
| Correspondent |
| Post Medical, Inc. |
| P.O. Box 29863 |
|
Atlanta,
GA
30359
|
|
| Correspondent Contact |
DAVID R THEAD |
| Regulation Number | 880.5570 |
| Classification Product Code |
|
| Date Received | 06/08/1997 |
| Decision Date | 08/15/1997 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
General Hospital
|
| 510k Review Panel |
General Hospital
|
| Statement |
Statement
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|