Device Classification Name |
Prosthesis, Vascular Graft, Of 6mm And Greater Diameter
|
510(k) Number |
K830543 |
Device Name |
VASCULAR GRAFT PROSTHESIS EXPANDED MICR |
Applicant |
IMPRA, INC. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Correspondent |
IMPRA, INC. |
4221 Richmond Rd., N.W. |
Walker,
MI
49534
|
|
Regulation Number | 870.3450
|
Classification Product Code |
|
Date Received | 02/22/1983 |
Decision Date | 07/19/1983 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Cardiovascular
|
510k Review Panel |
Cardiovascular
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|