Device Classification Name |
dura substitute
|
510(k) Number |
K131792 |
Device Name |
SYNTHECEL DURA REPAIR, SYNTHECEL DURA ONLAY |
Applicant |
SYNTHES INC |
1301 Goshen Parkway |
West Chester,
PA
19380
|
|
Applicant Contact |
HEATHER GUERIN |
Correspondent |
SYNTHES INC |
1301 Goshen Parkway |
West Chester,
PA
19380
|
|
Correspondent Contact |
HEATHER GUERIN |
Regulation Number | 882.5910
|
Classification Product Code |
|
Date Received | 06/18/2013 |
Decision Date | 12/16/2013 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Neurology
|
510k Review Panel |
Neurology
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
Recalls |
CDRH Recalls
|
|
|