Device Classification Name |
Bag, Urine Collection, Leg, For External Use, Sterile
|
510(k) Number |
K896728 |
Device Name |
4 SURE URINARY LEG BAG |
Applicant |
THE BOSTON & PACIFIC CO., INC. |
34 BREWSTER RD. |
HINGHAM,
MA
02043
|
|
Applicant Contact |
ORTIZ |
Correspondent |
THE BOSTON & PACIFIC CO., INC. |
34 BREWSTER RD. |
HINGHAM,
MA
02043
|
|
Correspondent Contact |
ORTIZ |
Regulation Number | 876.5250 |
Classification Product Code |
|
Date Received | 11/29/1989 |
Decision Date | 02/20/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Predetermined Change Control Plan Authorized |
No
|
|
|