Device Classification Name |
device, cystometric, hydraulic
|
510(k) Number |
K953451 |
Device Name |
UROPUMP TUBE & DAMPING CHAMGER |
Applicant |
LIFE-TECH INTL., INC. |
10920 KINGHURST |
HOUSTON,
TX
77099
|
|
Applicant Contact |
ALFRED C COATS |
Correspondent |
LIFE-TECH INTL., INC. |
10920 KINGHURST |
HOUSTON,
TX
77099
|
|
Correspondent Contact |
ALFRED C COATS |
Regulation Number | 876.1620
|
Classification Product Code |
|
Date Received | 07/18/1995 |
Decision Date | 10/05/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|