| Device Classification Name |
Tubes, Gastrointestinal (And Accessories)
|
| 510(k) Number |
K872096 |
| Device Name |
INFANT FEEDING KIT/SET NASOGASTRIC FEEDING KIT |
| Applicant |
| Tri-State Hospital Supply Corp. |
| 301 Catrell Dr. |
| P.O. Box 170 |
|
Howell,
MI
48843
|
|
| Applicant Contact |
GEORGE J PLUTA |
| Correspondent |
| Tri-State Hospital Supply Corp. |
| 301 Catrell Dr. |
| P.O. Box 170 |
|
Howell,
MI
48843
|
|
| Correspondent Contact |
GEORGE J PLUTA |
| Regulation Number | 876.5980 |
| Classification Product Code |
|
| Date Received | 06/01/1987 |
| Decision Date | 08/25/1987 |
| 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
|
|
|