| Device Classification Name |
Electrosurgical, Cutting & Coagulation & Accessories
|
| 510(k) Number |
K882049 |
| Device Name |
MEDITRON MG-1000 MONOPOLAR GENERATOR |
| Applicant |
| Xylog Corp. |
| 83 Hobart St. |
|
Hackensack,
NJ
07601
|
|
| Applicant Contact |
SAMUEL DICKSTEIN |
| Correspondent |
| Xylog Corp. |
| 83 Hobart St. |
|
Hackensack,
NJ
07601
|
|
| Correspondent Contact |
SAMUEL DICKSTEIN |
| Regulation Number | 878.4400 |
| Classification Product Code |
|
| Date Received | 05/16/1988 |
| Decision Date | 08/05/1988 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
General & Plastic Surgery
|
| 510k Review Panel |
General & Plastic Surgery
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|