Device Classification Name |
catheter, ventricular, general & plastic surgery
|
510(k) Number |
K851048 |
Device Name |
CHEST CATHETERS/THORACIC CATHETERS |
Applicant |
MEDOVATIONS, INC. |
11311 WEST LOCUST ST. |
WAUWATOSA,
WI
53222
|
|
Applicant Contact |
SURY R SHONEY |
Correspondent |
MEDOVATIONS, INC. |
11311 WEST LOCUST ST. |
WAUWATOSA,
WI
53222
|
|
Correspondent Contact |
SURY R SHONEY |
Regulation Number | 878.4200
|
Classification Product Code |
|
Date Received | 03/14/1985 |
Decision Date | 06/05/1985 |
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
|