Device Classification Name |
dura substitute
|
510(k) Number |
K072207 |
Device Name |
DURAGEN XS DURAL REGENERATION MATRIX |
Applicant |
INTEGRA LIFESCIENCES CORP. |
311C ENTERPRISE DRIVE |
PLAINSBORO,
NJ
08536
|
|
Applicant Contact |
PETER ALLAN |
Correspondent |
INTEGRA LIFESCIENCES CORP. |
311C ENTERPRISE DRIVE |
PLAINSBORO,
NJ
08536
|
|
Correspondent Contact |
PETER ALLAN |
Regulation Number | 882.5910
|
Classification Product Code |
|
Date Received | 08/08/2007 |
Decision Date | 08/23/2007 |
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
|
|
|