Device Classification Name |
Catheter, Retention Type, Balloon
|
510(k) Number |
K810691 |
Device Name |
CURITY 100% SILICONE IRRIGATION FOLEY |
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 | 876.5130
|
Classification Product Code |
|
Date Received | 03/13/1981 |
Decision Date | 03/13/1981 |
Decision |
SE - Postmarket Surveillance Required
(SESP) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|