Device Classification Name |
Garment, Protective, For Incontinence
|
510(k) Number |
K860459 |
Device Name |
UNITY DISPOSABLE INCONTINENT BRIEF |
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 | 02/06/1986 |
Decision Date | 02/26/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|