Device Classification Name |
catheter, umbilical artery
|
510(k) Number |
K921374 |
Device Name |
VYGON XRO VENOUS/ARTERIAL UMBILICAL CATHETER |
Applicant |
VYGON CORP. |
304 VERONA AVE. |
ELIZABETH,
NJ
07208
|
|
Applicant Contact |
HARRY SCHLAKMAN |
Correspondent |
VYGON CORP. |
304 VERONA AVE. |
ELIZABETH,
NJ
07208
|
|
Correspondent Contact |
HARRY SCHLAKMAN |
Regulation Number | 880.5200
|
Classification Product Code |
|
Date Received | 03/19/1992 |
Decision Date | 10/26/1992 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|