Device Classification Name |
prosthesis, vascular graft, of 6mm and greater diameter
|
510(k) Number |
K810376 |
Device Name |
MEADOX SZILAGYI GRAFT |
Applicant |
MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Correspondent |
MEADOX MEDICALS, DIV. BOSTON SCIENTIFIC CORP. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Regulation Number | 870.3450
|
Classification Product Code |
|
Date Received | 02/12/1981 |
Decision Date | 03/05/1981 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|