Device Classification Name |
Tubes, Gastrointestinal (And Accessories)
|
510(k) Number |
K926581 |
Device Name |
MIC TRANSGASTRIC JEJUNAL TUBE |
Applicant |
MEDICAL INNOVATIONS CORP. |
1595 MC-CANDLESS DR. |
MILPITAS,
CA
95035
|
|
Applicant Contact |
DENNIS WONG |
Correspondent |
MEDICAL INNOVATIONS CORP. |
1595 MC-CANDLESS DR. |
MILPITAS,
CA
95035
|
|
Correspondent Contact |
DENNIS WONG |
Regulation Number | 876.5980
|
Classification Product Code |
|
Date Received | 10/01/1992 |
Decision Date | 09/28/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|