Device Classification Name |
implant, malar
|
510(k) Number |
K902284 |
Device Name |
ZYMALAR IMPLANT |
Applicant |
APPLIED BIOMATERIAL TECHNOLOGIES |
851 SIXTH ST. S#145 |
BREMERTON,
WA
98310
|
|
Applicant Contact |
L HANSON |
Correspondent |
APPLIED BIOMATERIAL TECHNOLOGIES |
851 SIXTH ST. S#145 |
BREMERTON,
WA
98310
|
|
Correspondent Contact |
L HANSON |
Regulation Number | 878.3550
|
Classification Product Code |
|
Date Received | 05/22/1990 |
Decision Date | 09/12/1990 |
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
|
|
|