Device Classification Name |
Human Lyophilized Dura Mater
|
510(k) Number |
K910555 |
Device Name |
TUTOPLAST DURA |
Applicant |
PFRIMMER-VIGGO GMBH & CO. |
C/O KLEINFELD, KAPLAN & BECKER |
1140 NINETEENTH STREET, N. W. |
WASHINGTON,
DC
20036
|
|
Applicant Contact |
ALAN H KAPLAN |
Correspondent |
PFRIMMER-VIGGO GMBH & CO. |
C/O KLEINFELD, KAPLAN & BECKER |
1140 NINETEENTH STREET, N. W. |
WASHINGTON,
DC
20036
|
|
Correspondent Contact |
ALAN H KAPLAN |
Classification Product Code |
|
Date Received | 02/07/1991 |
Decision Date | 04/20/1992 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|