Device Classification Name |
Uroflowmeter
|
510(k) Number |
K904557 |
Device Name |
MICROFLO |
Applicant |
LIFE-TECH INTL., INC. |
P.O. BOX 36221 |
HOUSTON,
TX
77236 -6221
|
|
Applicant Contact |
COATS, MD |
Correspondent |
LIFE-TECH INTL., INC. |
P.O. BOX 36221 |
HOUSTON,
TX
77236 -6221
|
|
Correspondent Contact |
COATS, MD |
Regulation Number | 876.1800
|
Classification Product Code |
|
Date Received | 10/05/1990 |
Decision Date | 12/28/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|