| Device Classification Name |
Laparoscope, General & Plastic Surgery
|
| 510(k) Number |
K920040 |
| Device Name |
INTRADUCER |
| Applicant |
| Taut, Inc. |
| 2571 Kaneville Ct. |
|
Geneva,
IL
60134
|
|
| Applicant Contact |
KENSETH |
| Correspondent |
| Taut, Inc. |
| 2571 Kaneville Ct. |
|
Geneva,
IL
60134
|
|
| Correspondent Contact |
KENSETH |
| Regulation Number | 876.1500 |
| Classification Product Code |
|
| Date Received | 01/06/1992 |
| Decision Date | 02/28/1992 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Gastroenterology/Urology
|
| 510k Review Panel |
General & Plastic Surgery
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|