Device Classification Name |
Mesh, Surgical
|
510(k) Number |
K040364 |
Device Name |
MEDPOR CRANIOFACIAL IMPLANTS WITH EMBEDDED TITANIUM MESH |
Applicant |
POREX SURGICAL, INC. |
15 DART RD. |
NEWNAN,
GA
30265
|
|
Applicant Contact |
HOWARD MERCER |
Correspondent |
POREX SURGICAL, INC. |
15 DART RD. |
NEWNAN,
GA
30265
|
|
Correspondent Contact |
HOWARD MERCER |
Regulation Number | 878.3300
|
Classification Product Code |
|
Subsequent Product Code |
|
Date Received | 02/13/2004 |
Decision Date | 06/30/2004 |
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
|
Recalls |
CDRH Recalls
|
|
|