Device Classification Name |
catheter, intravascular, therapeutic, short-term less than 30 days
|
510(k) Number |
K941678 |
Device Name |
BIONECTOR |
Applicant |
VYGON CORP. |
ONE MADISON ST. |
EAST RUTHERFORD,
NJ
07073
|
|
Applicant Contact |
ROGER M SEVERN |
Correspondent |
VYGON CORP. |
ONE MADISON ST. |
EAST RUTHERFORD,
NJ
07073
|
|
Correspondent Contact |
ROGER M SEVERN |
Regulation Number | 880.5200
|
Classification Product Code |
|
Date Received | 04/05/1994 |
Decision Date | 06/26/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|