Device Classification Name |
Prosthesis, Tracheal, Expandable
|
510(k) Number |
K041269 |
Device Name |
ATRIUM MEDICAL CORPORATION ICAST COVERED STENT |
Applicant |
ATRIUM MEDICAL CORP. |
5 WENTWORTH DR. |
HUDSON,
NH
03051
|
|
Applicant Contact |
JOSEPH P DE PAOLO |
Correspondent |
ATRIUM MEDICAL CORP. |
5 WENTWORTH DR. |
HUDSON,
NH
03051
|
|
Correspondent Contact |
JOSEPH P DE PAOLO |
Regulation Number | 878.3720
|
Classification Product Code |
|
Date Received | 05/12/2004 |
Decision Date | 09/14/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|