Device Classification Name |
Cystometric Gas (Carbon-Dioxide) On Hydraulic Device
|
510(k) Number |
K862327 |
Device Name |
MODEL RCV REFLUX CHECK VALVE |
Applicant |
LIFE-TECH INTL., INC. |
P.O. BOX 36221 |
HOUSTON,
TX
77236 -6221
|
|
Applicant Contact |
COAT, M.D. |
Correspondent |
LIFE-TECH INTL., INC. |
P.O. BOX 36221 |
HOUSTON,
TX
77236 -6221
|
|
Correspondent Contact |
COAT, M.D. |
Regulation Number | 876.1620
|
Classification Product Code |
|
Date Received | 06/19/1986 |
Decision Date | 09/04/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|