Device Classification Name |
catheter, retention type, balloon
|
510(k) Number |
K902710 |
Device Name |
FOLEY CATHETER |
Applicant |
SOCIETA GRUPPI ELASTOMERI S.A. |
VIA STEFANO FRANSCINI 24 |
6850 MENDRISIO (CH) |
MENDRISIO,
ES
|
|
Applicant Contact |
TOZZI FONTANA |
Correspondent |
SOCIETA GRUPPI ELASTOMERI S.A. |
VIA STEFANO FRANSCINI 24 |
6850 MENDRISIO (CH) |
MENDRISIO,
ES
|
|
Correspondent Contact |
TOZZI FONTANA |
Regulation Number | 876.5130
|
Classification Product Code |
|
Date Received | 06/20/1990 |
Decision Date | 11/21/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|