Device Classification Name |
Catheter, Urethral
|
510(k) Number |
K993651 |
Device Name |
O'NEIL STERILE FIELD INTERMITTENT URINARY CATHETER |
Applicant |
SC HENNIG ENTERPRISES EUROPE SRL |
25 SHANN ST. |
FLOREAT PARK |
WESTERN AUSTRALIA,
AU
6014
|
|
Applicant Contact |
GEORGE O'NEIL |
Correspondent |
SC HENNIG ENTERPRISES EUROPE SRL |
25 SHANN ST. |
FLOREAT PARK |
WESTERN AUSTRALIA,
AU
6014
|
|
Correspondent Contact |
GEORGE O'NEIL |
Regulation Number | 876.5130
|
Classification Product Code |
|
Date Received | 10/29/1999 |
Decision Date | 12/23/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Gastroenterology/Urology
|
510k Review Panel |
Gastroenterology/Urology
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|