Device Classification Name |
system, urine drainage, closed, for nonindwelling catheter, sterile
|
510(k) Number |
K901000 |
Device Name |
URO TEX URINALS |
Applicant |
SIERRA LABORATORIES, INC. |
3520 S. CAMPBELL AVE. |
P.O. BOX 27005 |
TUCSON,
AZ
85726
|
|
Applicant Contact |
KLUG, PHD |
Correspondent |
SIERRA LABORATORIES, INC. |
3520 S. CAMPBELL AVE. |
P.O. BOX 27005 |
TUCSON,
AZ
85726
|
|
Correspondent Contact |
KLUG, PHD |
Regulation Number | 876.5250
|
Classification Product Code |
|
Date Received | 03/02/1990 |
Decision Date | 03/26/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|