Device Classification Name |
catheter, urological
|
510(k) Number |
K760259 |
Device Name |
CATHETER 3-WAY SILICONE FOLEY |
Applicant |
TRAVENOL LABORATORIES, S.A. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
TRAVENOL LABORATORIES, S.A. |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 876.5130
|
Classification Product Code |
|
Date Received | 07/20/1976 |
Decision Date | 08/23/1976 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|