Device Classification Name |
cystometric gas (carbon-dioxide) on hydraulic device
|
510(k) Number |
K920777 |
Device Name |
LABORIE URODYNAMICS PROCESSOR |
Applicant |
R. LABORIE SURGICAL LTD. |
45 WEST ST. |
SUITE 2 |
ATTLEBORO,
MA
02703
|
|
Applicant Contact |
JAMES R VEALE |
Correspondent |
R. LABORIE SURGICAL LTD. |
45 WEST ST. |
SUITE 2 |
ATTLEBORO,
MA
02703
|
|
Correspondent Contact |
JAMES R VEALE |
Regulation Number | 876.1620
|
Classification Product Code |
|
Date Received | 02/20/1992 |
Decision Date | 09/04/1992 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|