Device Classification Name |
Device, Incontinence, Urosheath Type, Sterile
|
510(k) Number |
K970966 |
Device Name |
COMFORT CATH CHOICE MALE EXTERNAL CATHETER |
Applicant |
SIERRA LABORATORIES, INC. |
3520 SOUTH CAMPBELL AVE. |
TUCSON,
AZ
85713
|
|
Applicant Contact |
ANNA PEREZ |
Correspondent |
SIERRA LABORATORIES, INC. |
3520 SOUTH CAMPBELL AVE. |
TUCSON,
AZ
85713
|
|
Correspondent Contact |
ANNA PEREZ |
Regulation Number | 876.5250
|
Classification Product Code |
|
Date Received | 03/17/1997 |
Decision Date | 04/22/1997 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|