Device Classification Name |
dura substitute
|
510(k) Number |
K982282 |
Device Name |
DURA-GUARD - DURAL REPAIR PATCH |
Applicant |
BIO-VASCULAR, INC. |
2575 UNIVERSITY AVE. |
ST. PAUL,
MN
55114 -1024
|
|
Applicant Contact |
MARY FRICK |
Correspondent |
BIO-VASCULAR, INC. |
2575 UNIVERSITY AVE. |
ST. PAUL,
MN
55114 -1024
|
|
Correspondent Contact |
MARY FRICK |
Regulation Number | 882.5910
|
Classification Product Code |
|
Date Received | 06/30/1998 |
Decision Date | 07/30/1998 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Special
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|