| Device Classification Name |
Tubes, Gastrointestinal (And Accessories)
|
| 510(k) Number |
K883319 |
| Device Name |
HILL NASOGASTRIC TUBE |
| Applicant |
| Zinetics Medical, Inc. |
| Forty-Eight Tempest Park |
| 2212 S. W. Temple |
|
Salt Lake City,
UT
84115
|
|
| Applicant Contact |
RUSS A GARRISON |
| Correspondent |
| Zinetics Medical, Inc. |
| Forty-Eight Tempest Park |
| 2212 S. W. Temple |
|
Salt Lake City,
UT
84115
|
|
| Correspondent Contact |
RUSS A GARRISON |
| Regulation Number | 876.5980 |
| Classification Product Code |
|
| Date Received | 08/05/1988 |
| Decision Date | 12/05/1988 |
| 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
|
|
|