Device Classification Name |
Dura Substitute
|
510(k) Number |
K984534 |
FOIA Releasable 510(k) |
K984534
|
Device Name |
PRECLUDE ACUSEAL DURA SUBSTITUTE |
Applicant |
W.L. GORE & ASSOCIATES,INC |
301 AIRPORT RD |
ELKTON,
MD
21922 -1408
|
|
Applicant Contact |
JOHN NICHOLSON |
Correspondent |
W.L. GORE & ASSOCIATES,INC |
301 AIRPORT RD |
ELKTON,
MD
21922 -1408
|
|
Correspondent Contact |
JOHN NICHOLSON |
Regulation Number | 882.5910
|
Classification Product Code |
|
Date Received | 12/21/1998 |
Decision Date | 03/15/1999 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|