Device Classification Name |
Catheter, Intravascular, Therapeutic, Short-Term Less Than 30 Days
|
510(k) Number |
K901640 |
Device Name |
MULTICATH PLACEMENT KIT |
Applicant |
VYGON CORP. |
227 BROADWAY |
SUITE 100 |
NEW YORK,
NY
10007
|
|
Applicant Contact |
HARRY A SCHLAKMAN |
Correspondent |
VYGON CORP. |
227 BROADWAY |
SUITE 100 |
NEW YORK,
NY
10007
|
|
Correspondent Contact |
HARRY A SCHLAKMAN |
Regulation Number | 880.5200
|
Classification Product Code |
|
Date Received | 04/09/1990 |
Decision Date | 08/10/1990 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|