Device Classification Name |
Mesh, Surgical
|
510(k) Number |
K051879 |
Device Name |
SYNTHES (USA) POROUS POLYETHYLENE IMPLANTS |
Applicant |
SYNTHES (USA) |
1302 WRIGHTS LANE EAST |
WEST CHESTER,
PA
19380
|
|
Applicant Contact |
KATHY ANDERSON |
Correspondent |
SYNTHES (USA) |
1302 WRIGHTS LANE EAST |
WEST CHESTER,
PA
19380
|
|
Correspondent Contact |
KATHY ANDERSON |
Regulation Number | 878.3300
|
Classification Product Code |
|
Subsequent Product Codes |
|
Date Received | 07/11/2005 |
Decision Date | 10/05/2005 |
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
|