| Device Classification Name |
Tubes, Gastrointestinal (And Accessories)
|
| 510(k) Number |
K895706 |
| Device Name |
TUBING ORGANIZER |
| Applicant |
| 3t Products, Inc. |
| 16046 W. 13 Mile Rd. |
|
Birmingham,
MI
48009
|
|
| Applicant Contact |
TIMOTHY SIMMONS |
| Correspondent |
| 3t Products, Inc. |
| 16046 W. 13 Mile Rd. |
|
Birmingham,
MI
48009
|
|
| Correspondent Contact |
TIMOTHY SIMMONS |
| Regulation Number | 876.5980 |
| Classification Product Code |
|
| Date Received | 09/25/1989 |
| Decision Date | 10/31/1989 |
| Decision |
Substantially Equivalent
(SESE) |
| Regulation Medical Specialty |
Gastroenterology/Urology
|
| 510k Review Panel |
Gastroenterology/Urology
|
| Type |
Traditional
|
| Reviewed by Third Party |
No
|
| Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|