Device Classification Name |
cystometric gas (carbon-dioxide) on hydraulic device
|
510(k) Number |
K833628 |
Device Name |
LUMEN-4 URODYNAMIC CATHETER |
Applicant |
SURGITEK |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
SURGITEK |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 876.1620
|
Classification Product Code |
|
Date Received | 10/14/1983 |
Decision Date | 11/28/1983 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|