Device Classification Name |
Material, Polytetrafluoroethylene Vitreous Carbon, For Maxillofacial Reconstruction
|
510(k) Number |
K111323 |
Device Name |
SYNTHES SYNPOR HD POROUS POLYETHYLENE THRER DIMENSIONAL IMPLANTS |
Applicant |
SYNTHES INC |
1301 Goshen Parkway |
West Chester,
PA
19380
|
|
Applicant Contact |
ALAN T HALEY |
Correspondent |
SYNTHES INC |
1301 Goshen Parkway |
West Chester,
PA
19380
|
|
Correspondent Contact |
ALAN T HALEY |
Regulation Number | 878.3500
|
Classification Product Code |
|
Date Received | 05/11/2011 |
Decision Date | 11/16/2011 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Summary |
Summary
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|