Device Classification Name |
Collector, Urine, (And Accessories) For Indwelling Catheter
|
510(k) Number |
K841169 |
Device Name |
CURITY RIG FOLEY CATH TRAY |
Applicant |
THE KENDAL CO. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Correspondent |
THE KENDAL CO. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Regulation Number | 876.5250 |
Classification Product Code |
|
Date Received | 03/19/1984 |
Decision Date | 07/06/1984 |
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
|
|
|