Device Classification Name |
Device, Incontinence, Urosheath Type, Sterile
|
510(k) Number |
K934266 |
Device Name |
COMFORT CATH SELF ADHERING MALE EXTERNAL CATHETER |
Applicant |
SIERRA LABORATORIES, INC. |
3520 SOUTH CAMPBELL AVE. |
TUCSON,
AZ
85713
|
|
Applicant Contact |
ROBERT J KLUG, PHD |
Correspondent |
SIERRA LABORATORIES, INC. |
3520 SOUTH CAMPBELL AVE. |
TUCSON,
AZ
85713
|
|
Correspondent Contact |
ROBERT J KLUG, PHD |
Regulation Number | 876.5250
|
Classification Product Code |
|
Date Received | 08/31/1993 |
Decision Date | 04/19/1994 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|