Device Classification Name |
Collector, Urine, (And Accessories) For Indwelling Catheter
|
510(k) Number |
K813621 |
Device Name |
CURITY BEDSIDE DRAINAGE BAG |
Applicant |
THE KENDAL CO. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
THE KENDAL CO. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 876.5250 |
Classification Product Code |
|
Date Received | 12/29/1981 |
Decision Date | 02/12/1982 |
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
|
|
|