Device Classification Name |
tray, catheterization, sterile urethral, with or without catheter (kit)
|
510(k) Number |
K910653 |
Device Name |
TOUCHLESS II INTERMITTENT CATHETER |
Applicant |
C.R. BARD, INC. |
111 SPRING ST. |
MURRAY HILL,
NJ
07974
|
|
Applicant Contact |
JOHN HOFFER |
Correspondent |
C.R. BARD, INC. |
111 SPRING ST. |
MURRAY HILL,
NJ
07974
|
|
Correspondent Contact |
JOHN HOFFER |
Regulation Number | 876.5130
|
Classification Product Code |
|
Date Received | 02/14/1991 |
Decision Date | 05/06/1991 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|