Device Classification Name |
Catheter, Ventricular, General & Plastic Surgery
|
510(k) Number |
K870015 |
Device Name |
HCI ALL PURPOSE DRAIN/CATHETER SET |
Applicant |
HEALTH CARE INNOVATIONS, INC. |
609 DUNDEE RD. |
GLENCOE,
IL
60022
|
|
Applicant Contact |
CRAIG S STEADMAN |
Correspondent |
HEALTH CARE INNOVATIONS, INC. |
609 DUNDEE RD. |
GLENCOE,
IL
60022
|
|
Correspondent Contact |
CRAIG S STEADMAN |
Regulation Number | 878.4200
|
Classification Product Code |
|
Date Received | 01/02/1987 |
Decision Date | 02/06/1987 |
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
|