Device Classification Name |
Implant, Muscle, Pectoralis
|
510(k) Number |
K913768 |
Device Name |
PEC IMPLANT |
Applicant |
APPLIED BIOMATERIAL TECHNOLOGIES |
3500 N.W. ANDERSON HILL RD. |
SUITE #101 |
SILVERDALE,
WA
98383
|
|
Applicant Contact |
GERALD L HANSON |
Correspondent |
APPLIED BIOMATERIAL TECHNOLOGIES |
3500 N.W. ANDERSON HILL RD. |
SUITE #101 |
SILVERDALE,
WA
98383
|
|
Correspondent Contact |
GERALD L HANSON |
Regulation Number | 874.3620
|
Classification Product Code |
|
Date Received | 08/22/1991 |
Decision Date | 02/03/1992 |
Decision |
Substantially Equivalent
(SESE) |
Regulation Medical Specialty |
Ear Nose & Throat
|
510k Review Panel |
General & Plastic Surgery
|
Type |
Traditional
|
Reviewed by Third Party |
No
|
Combination Product |
No
|
|
|