| Device Classification Name |
Instrument, Biopsy, Suction
|
| 510(k) Number |
K902097 |
| Device Name |
MODEL TR RECTAL SUCTION BIOPSY TUBE |
| Applicant |
| Medical Measurements, Inc. |
| 53 Main St. |
|
Hackensack,
NJ
07601
|
|
| Applicant Contact |
WILLIAM SONES |
| Correspondent |
| Medical Measurements, Inc. |
| 53 Main St. |
|
Hackensack,
NJ
07601
|
|
| Correspondent Contact |
WILLIAM SONES |
| Regulation Number | 876.1075 |
| Classification Product Code |
|
| Date Received | 05/08/1990 |
| Decision Date | 07/27/1990 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Gastroenterology/Urology
|
| 510k Review Panel |
Gastroenterology/Urology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|