Device Classification Name |
tubes, gastrointestinal (and accessories)
|
510(k) Number |
K900464 |
Device Name |
MIC PERCUTANEOUS ENDOSCOPIC GASTROSTOMY TUBE |
Applicant |
MEDICAL INNOVATIONS CORP. |
1595 MC-CANDLESS DR. |
MILPITAS,
CA
95035
|
|
Applicant Contact |
STEPHEN K PARKS |
Correspondent |
MEDICAL INNOVATIONS CORP. |
1595 MC-CANDLESS DR. |
MILPITAS,
CA
95035
|
|
Correspondent Contact |
STEPHEN K PARKS |
Regulation Number | 876.5980
|
Classification Product Code |
|
Date Received | 01/31/1990 |
Decision Date | 12/05/1990 |
Decision |
Substantially Equivalent - Kit With Drugs
(SEKD) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|