| Device Classification Name |
Laparoscope, Gynecologic (And Accessories)
|
| 510(k) Number |
K941944 |
| Device Name |
TAHOE SURGICAL INSTRUMENTS LIGATURE DEVICE |
| Applicant |
| Tahoe Surgical Instruments P.R., Inc. |
| P.O. Box 1449 |
|
Vega Baja,
PR
00694
|
|
| Applicant Contact |
JON A STEVENS |
| Correspondent |
| Tahoe Surgical Instruments P.R., Inc. |
| P.O. Box 1449 |
|
Vega Baja,
PR
00694
|
|
| Correspondent Contact |
JON A STEVENS |
| Regulation Number | 884.1720 |
| Classification Product Code |
|
| Date Received | 04/21/1994 |
| Decision Date | 07/25/1994 |
| 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
|
|
|