Device Classification Name |
Collector, Urine, (And Accessories) For Indwelling Catheter
|
510(k) Number |
K852085 |
Device Name |
KENDALL CURITY URINARY OUTPUT MONITOR DRAINAGE BAG |
Applicant |
THE KENDAL CO. |
ONE FEDERAL ST. |
BOSTON,
MA
02110 -2003
|
|
Applicant Contact |
MARK W WENZEL |
Correspondent |
THE KENDAL CO. |
ONE FEDERAL ST. |
BOSTON,
MA
02110 -2003
|
|
Correspondent Contact |
MARK W WENZEL |
Regulation Number | 876.5250 |
Classification Product Code |
|
Date Received | 05/13/1985 |
Decision Date | 08/07/1985 |
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
|
|
|