Device Classification Name |
Dura Substitute
|
510(k) Number |
K950956 |
Device Name |
DURA-GUARD DURAL REPAIR PATCH, DURA-GUARD DURA SUBSTITUTE |
Applicant |
BIO-VASCULAR, INC. |
2670 PATTON RD. |
SAINT PAUL,
MN
55113
|
|
Applicant Contact |
BRUCE A MACFARLANE |
Correspondent |
BIO-VASCULAR, INC. |
2670 PATTON RD. |
SAINT PAUL,
MN
55113
|
|
Correspondent Contact |
BRUCE A MACFARLANE |
Regulation Number | 882.5910
|
Classification Product Code |
|
Date Received | 03/02/1995 |
Decision Date | 06/02/1995 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|