Device Classification Name |
Prosthesis, Chin, Internal
|
510(k) Number |
K863941 |
Device Name |
POREX(TM) PROSTHESIS, CHIN, INTERNAL |
Applicant |
POREX MEDICAL |
500 BOHANNON RD. |
FAIRBURN,
GA
30213
|
|
Applicant Contact |
HOWARD A MERCER,PHD |
Correspondent |
POREX MEDICAL |
500 BOHANNON RD. |
FAIRBURN,
GA
30213
|
|
Correspondent Contact |
HOWARD A MERCER,PHD |
Regulation Number | 878.3550
|
Classification Product Code |
|
Date Received | 10/10/1986 |
Decision Date | 10/24/1986 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
General & Plastic Surgery
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|