| Device Classification Name |
Laparoscope, General & Plastic Surgery
|
| 510(k) Number |
K926078 |
| Device Name |
DMI TOCAR AND CANNULA SYSTEM |
| Applicant |
| DIVERSIFIED MEDICAL INSTRUMENTS, INC. |
| 4519 TARALEY COURT |
|
ELLICOTT CITY,
MD
21042
|
|
| Applicant Contact |
CHARLES J SALBERG |
| Correspondent |
| DIVERSIFIED MEDICAL INSTRUMENTS, INC. |
| 4519 TARALEY COURT |
|
ELLICOTT CITY,
MD
21042
|
|
| Correspondent Contact |
CHARLES J SALBERG |
| Regulation Number | 876.1500 |
| Classification Product Code |
|
| Date Received | 12/01/1992 |
| Decision Date | 05/17/1993 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Gastroenterology/Urology
|
| 510k Review Panel |
General & Plastic Surgery
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|