| Device Classification Name |
Coagulator-Cutter, Endoscopic, Unipolar (And Accessories)
|
| 510(k) Number |
K772220 |
| Device Name |
PROBE, COAGULATION ACCESSORY |
| Applicant |
| Kli |
| 4221 Richmond Rd., NW |
|
Walker,
MI
49534
|
|
| Correspondent |
| Kli |
| 4221 Richmond Rd., NW |
|
Walker,
MI
49534
|
|
| Regulation Number | 884.4160 |
| Classification Product Code |
|
| Date Received | 12/05/1977 |
| Decision Date | 12/13/1977 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Obstetrics/Gynecology
|
| 510k Review Panel |
Obstetrics/Gynecology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|