Device Classification Name |
catheter, peritoneal
|
510(k) Number |
K894119 |
Device Name |
MADEGOM LTDA. PENROSE DRAIN TUBING |
Applicant |
MADEGOM |
CASILLA POSTAL 85 |
11 SANTIAGO |
CHILE,
CL
|
|
Applicant Contact |
ALEJANDRO MIRALLES |
Correspondent |
MADEGOM |
CASILLA POSTAL 85 |
11 SANTIAGO |
CHILE,
CL
|
|
Correspondent Contact |
ALEJANDRO MIRALLES |
Regulation Number | 878.4200
|
Classification Product Code |
|
Date Received | 06/12/1989 |
Decision Date | 08/18/1989 |
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
|