Device Classification Name |
prosthesis, chin, internal
|
510(k) Number |
K152463 |
Device Name |
SU-POR Patient-Specific Cranial Implant, SU-POR Patient-Specific Facial Implant |
Applicant |
PORIFEROUS LLC |
535 PINE ROAD, SUITE 206 |
NEWNAN,
GA
30263 -7640
|
|
Applicant Contact |
JERRI L. MANN |
Correspondent |
PORIFEROUS LLC |
535 PINE ROAD, SUITE 206 |
NEWNAN,
GA
30263 -7640
|
|
Correspondent Contact |
JERRI L. MANN |
Regulation Number | 878.3550
|
Classification Product Code |
|
Date Received | 08/28/2015 |
Decision Date | 01/20/2016 |
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
|