Device Classification Name |
catheter (gastric, colonic, etc.), irrigation and aspiration
|
510(k) Number |
K951533 |
Device Name |
EASI-LAV PEDIATRIC / ADULT GASTRIC LAVAGE KIT |
Applicant |
BALLARD MEDICAL PRODUCTS |
12050 LONE PEAK PKWY. |
DRAPER,
UT
84020
|
|
Applicant Contact |
E. M CHAMBERLAIN |
Correspondent |
BALLARD MEDICAL PRODUCTS |
12050 LONE PEAK PKWY. |
DRAPER,
UT
84020
|
|
Correspondent Contact |
E. M CHAMBERLAIN |
Regulation Number | 876.5980
|
Classification Product Code |
|
Date Received | 04/03/1995 |
Decision Date | 07/05/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|