| Device Classification Name |
Electrosurgical, Cutting & Coagulation & Accessories
|
| 510(k) Number |
K870981 |
| Device Name |
MODEL 8700 BIPOLAR ELECTROSURGICAL GENERATOR |
| Applicant |
| Everest Medical Corp. |
| 6601 Shingle Creek Pkwy. |
| Suite 400 |
|
Brooklyn Center,
MN
55430
|
|
| Applicant Contact |
DWAYNE K BUCHHOLZ |
| Correspondent |
| Everest Medical Corp. |
| 6601 Shingle Creek Pkwy. |
| Suite 400 |
|
Brooklyn Center,
MN
55430
|
|
| Correspondent Contact |
DWAYNE K BUCHHOLZ |
| Regulation Number | 878.4400 |
| Classification Product Code |
|
| Date Received | 03/10/1987 |
| Decision Date | 05/06/1987 |
| 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
|