Device Classification Name |
Prosthesis, Chin, Internal
|
510(k) Number |
K863397 |
Device Name |
BYRON SILICONE CHIN IMPLANTS |
Applicant |
BYRON MEDICAL |
3280 E. HEMISPHERE LOOP |
SUITE 100 |
TUCSON,
AZ
85706
|
|
Applicant Contact |
BYRON ECONOMIDY |
Correspondent |
BYRON MEDICAL |
3280 E. HEMISPHERE LOOP |
SUITE 100 |
TUCSON,
AZ
85706
|
|
Correspondent Contact |
BYRON ECONOMIDY |
Regulation Number | 878.3550
|
Classification Product Code |
|
Date Received | 09/03/1986 |
Decision Date | 09/18/1986 |
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
|