| Device Classification Name |
Electrosurgical, Cutting & Coagulation & Accessories
|
| 510(k) Number |
K964143 |
| Device Name |
MINI-SYMM BIPOLAR COAGULATOR |
| Applicant |
| Valley Forge Scientific Corp. |
| 136 Green Tree Rd. |
| P.O. Box 1179 |
|
Oaks,
PA
19456
|
|
| Applicant Contact |
JERRY L MALIS |
| Correspondent |
| Valley Forge Scientific Corp. |
| 136 Green Tree Rd. |
| P.O. Box 1179 |
|
Oaks,
PA
19456
|
|
| Correspondent Contact |
JERRY L MALIS |
| Regulation Number | 878.4400 |
| Classification Product Code |
|
| Date Received | 10/17/1996 |
| Decision Date | 01/09/1997 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
General & Plastic Surgery
|
| 510k Review Panel |
General & Plastic Surgery
|
| Summary |
Summary
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|