Device Classification Name |
Bulb, Inflation, For Endoscope
|
510(k) Number |
K900016 |
Device Name |
TRANS/R - FP(3) |
Applicant |
CIVCO MEDICAL INSTRUMENTS CO., INC. |
418 B AVE. |
KALONA,
IA
52247
|
|
Applicant Contact |
J WEDEL |
Correspondent |
CIVCO MEDICAL INSTRUMENTS CO., INC. |
418 B AVE. |
KALONA,
IA
52247
|
|
Correspondent Contact |
J WEDEL |
Regulation Number | 876.1500
|
Classification Product Code |
|
Date Received | 01/02/1990 |
Decision Date | 06/11/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|