Device Classification Name |
Cystometric Gas (Carbon-Dioxide) On Hydraulic Device
|
510(k) Number |
K800822 |
Device Name |
CO2 CYSTOSCOPY/URETHROSCOPY CONSOLE |
Applicant |
KLI |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Correspondent |
KLI |
803 N. Front St. Suite 3 |
McHenry,
IL
60050
|
|
Regulation Number | 876.1620 |
Classification Product Code |
|
Date Received | 04/14/1980 |
Decision Date | 06/17/1980 |
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
|