Device Classification Name |
sheath, corrugated rubber, for nonindwelling catheter, sterile
|
510(k) Number |
K883119 |
Device Name |
VPI NON-ADHESIVE CONDOM CATHETER |
Applicant |
COOK UROLOGICAL, INC. |
1100 WEST MORGAN ST. |
P.O. BOX 227 |
SPENCER,
IN
47460
|
|
Applicant Contact |
SUE SMITH |
Correspondent |
COOK UROLOGICAL, INC. |
1100 WEST MORGAN ST. |
P.O. BOX 227 |
SPENCER,
IN
47460
|
|
Correspondent Contact |
SUE SMITH |
Regulation Number | 876.5250
|
Classification Product Code |
|
Date Received | 07/25/1988 |
Decision Date | 08/02/1988 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|