Device Classification Name |
cystometric gas (carbon-dioxide) on hydraulic device
|
510(k) Number |
K853936 |
Device Name |
1351 UROFLOW AUTO START |
Applicant |
LIFE-TECH INTL., INC. |
10515 HARWIN DR. |
P.O.B OX 36221 |
HOUSTON,
TX
77036
|
|
Applicant Contact |
ALFRED C COATS |
Correspondent |
LIFE-TECH INTL., INC. |
10515 HARWIN DR. |
P.O.B OX 36221 |
HOUSTON,
TX
77036
|
|
Correspondent Contact |
ALFRED C COATS |
Regulation Number | 876.1620
|
Classification Product Code |
|
Date Received | 09/24/1985 |
Decision Date | 12/02/1985 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|