| Device Classification Name |
Laparoscope, General & Plastic Surgery
|
| 510(k) Number |
K915790 |
| Device Name |
ENDO-GARD ELECTROSURGICAL TROCAR |
| Applicant |
| Conmedcorp |
| 310 Broad St. |
|
Utica,
NY
13501 -1203
|
|
| Applicant Contact |
MARTIN P FORTE |
| Correspondent |
| Conmedcorp |
| 310 Broad St. |
|
Utica,
NY
13501 -1203
|
|
| Correspondent Contact |
MARTIN P FORTE |
| Regulation Number | 876.1500 |
| Classification Product Code |
|
| Date Received | 12/24/1991 |
| Decision Date | 10/09/1992 |
| 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
|