| Device Classification Name |
Tube, Feeding
|
| 510(k) Number |
K890116 |
| Device Name |
ENTERAL FEEDING TUBE |
| Applicant |
| Hdc Corp. |
| 2551 Casey Ave. |
|
Mountain View,
CA
94043
|
|
| Applicant Contact |
L COLEMAN |
| Correspondent |
| Hdc Corp. |
| 2551 Casey Ave. |
|
Mountain View,
CA
94043
|
|
| Correspondent Contact |
L COLEMAN |
| Regulation Number | 876.5980 |
| Classification Product Code |
|
| Date Received | 01/11/1989 |
| Decision Date | 04/05/1989 |
| 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
|
|
|