Device Classification Name |
garment, protective, for incontinence
|
510(k) Number |
K852276 |
Device Name |
ESTEEM INCONTINENT SYSTEM |
Applicant |
BEVAN MEDICAL, INC. |
1 GREENSBORO DR. |
REXDALE,
CA
|
|
Applicant Contact |
SAL BEVAN |
Correspondent |
BEVAN MEDICAL, INC. |
1 GREENSBORO DR. |
REXDALE,
CA
|
|
Correspondent Contact |
SAL BEVAN |
Regulation Number | 876.5920
|
Classification Product Code |
|
Date Received | 05/29/1985 |
Decision Date | 08/07/1985 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|