| Device Classification Name |
instrument, biopsy
|
|---|
| 510(k) Number |
K902461 |
|---|
| Device Name |
MEADOX SURGIMED BIOPSY GUN AND NEEDLE |
|---|
| Applicant |
| MEADOX SURGIMED, INC. |
| 112 BAUER DR. |
|
OAKLAND,
NJ
07436
|
|
| Applicant Contact |
PATRICIA G SCHARF |
| Correspondent |
| MEADOX SURGIMED, INC. |
| 112 BAUER DR. |
|
OAKLAND,
NJ
07436
|
|
| Correspondent Contact |
PATRICIA G SCHARF |
| Regulation Number | 876.1075
|
|---|
| Classification Product Code |
|
|---|
| Date Received | 06/04/1990 |
|---|
| Decision Date | 07/16/1990 |
|---|
| Decision |
Substantially Equivalent
(SESE) |
|---|
| Regulation Medical Specialty |
Gastroenterology/Urology
|
|---|
| 510k Review Panel |
Gastroenterology/Urology
|
|---|
| Type |
Traditional
|
|---|
| Reviewed by Third Party |
No
|
|---|
| Combination Product |
No
|
|---|