Device Classification Name |
Catheter, Irrigation
|
510(k) Number |
K895516 |
Device Name |
CAVITY DRAINAGE CATHETERIZATION SET, CS-01600 |
Applicant |
ARROW INTL., INC. |
P.O. BOX 6306 |
HILL AND GEORGE AVENUES |
READING,
PA
19610
|
|
Applicant Contact |
THOMAS D NICKEL |
Correspondent |
ARROW INTL., INC. |
P.O. BOX 6306 |
HILL AND GEORGE AVENUES |
READING,
PA
19610
|
|
Correspondent Contact |
THOMAS D NICKEL |
Regulation Number | 878.4200
|
Classification Product Code |
|
Date Received | 09/12/1989 |
Decision Date | 12/27/1989 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|