Device Classification Name |
port & catheter, implanted, subcutaneous, intravascular
|
510(k) Number |
K112713 |
Device Name |
NORFOLK MEDICAL-SPORTPORT-FAMILY OF PORTS |
Applicant |
NORFOLK MEDICAL PRODUCTS, INC. |
7350 NORTH RIDGEWAY |
SKOKIE,
IL
60076
|
|
Applicant Contact |
MICHAEL DALTON |
Correspondent |
NORFOLK MEDICAL PRODUCTS, INC. |
7350 NORTH RIDGEWAY |
SKOKIE,
IL
60076
|
|
Correspondent Contact |
MICHAEL DALTON |
Regulation Number | 880.5965
|
Classification Product Code |
|
Date Received | 09/19/2011 |
Decision Date | 10/27/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General Hospital
|
510k Review Panel |
General Hospital
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|