| Device Classification Name |
Tubes, Gastrointestinal (And Accessories)
|
| 510(k) Number |
K862855 |
| Device Name |
CRAIG NASO-GASTRIC TUBE HOLDER |
| Applicant |
| Henley Intl. |
| 10518 Kinghurst |
|
Houston,
TX
77099
|
|
| Applicant Contact |
ERNEST J HENLEY |
| Correspondent |
| Henley Intl. |
| 10518 Kinghurst |
|
Houston,
TX
77099
|
|
| Correspondent Contact |
ERNEST J HENLEY |
| Regulation Number | 876.5980 |
| Classification Product Code |
|
| Date Received | 07/29/1986 |
| Decision Date | 11/04/1986 |
| 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
|
|
|