Device Classification Name |
Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
|
510(k) Number |
K034010 |
Device Name |
GELSOFT PLUS ERS |
Applicant |
VASCUTEK LTD. |
6200 JACKSON RD. |
ANN ARBOR,
MI
48103 -9300
|
|
Applicant Contact |
STEVEN ARICK |
Correspondent |
VASCUTEK LTD. |
6200 JACKSON RD. |
ANN ARBOR,
MI
48103 -9300
|
|
Correspondent Contact |
STEVEN ARICK |
Regulation Number | 870.3450
|
Classification Product Code |
|
Date Received | 12/24/2003 |
Decision Date | 02/19/2004 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Statement |
Statement
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|