Device Classification Name |
tubes, gastrointestinal (and accessories)
|
510(k) Number |
K133077 |
Device Name |
GENERICA MEDICAL ENTERNAL DELIVERY; PUMP BAG SET, PUMP SPIKE SET, GRAVITY BAG SET |
Applicant |
GENERICA MEDICAL INTERNATIONAL, INC. |
1910 D ST. |
LAVERNE,
CA
91750
|
|
Applicant Contact |
JIM BARLEY |
Correspondent |
GENERICA MEDICAL INTERNATIONAL, INC. |
1910 D ST. |
LAVERNE,
CA
91750
|
|
Correspondent Contact |
JIM BARLEY |
Regulation Number | 876.5980
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 09/30/2013 |
Decision Date | 07/28/2014 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|