Device Classification Name |
Tubes, Gastrointestinal (And Accessories)
|
510(k) Number |
K875126 |
Device Name |
MIC (SPECIFIC LINE) INSERTION KIT |
Applicant |
MEDICAL INNOVATIONS CORP. |
1595 MC-CANDLESS DR. |
MILPITAS,
CA
95035
|
|
Applicant Contact |
REBECCA ANDERSEN |
Correspondent |
MEDICAL INNOVATIONS CORP. |
1595 MC-CANDLESS DR. |
MILPITAS,
CA
95035
|
|
Correspondent Contact |
REBECCA ANDERSEN |
Regulation Number | 876.5980
|
Classification Product Code |
|
Date Received | 12/15/1987 |
Decision Date | 03/02/1988 |
Decision |
Substantially Equivalent - With Drug
(SESD) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|