Device Classification Name |
Prosthesis, Chin, Internal
|
510(k) Number |
K971478 |
Device Name |
DURALASTIC ANATOMICAL CHIN IMPLANTS |
Applicant |
ALLIED BIOMEDICAL CORP. |
3850 RAMADA DR., SUITE C-2 |
PASO ROBLES,
CA
93446
|
|
Applicant Contact |
GERALD HANSON |
Correspondent |
ALLIED BIOMEDICAL CORP. |
3850 RAMADA DR., SUITE C-2 |
PASO ROBLES,
CA
93446
|
|
Correspondent Contact |
GERALD HANSON |
Regulation Number | 878.3550
|
Classification Product Code |
|
Date Received | 04/23/1997 |
Decision Date | 07/18/1997 |
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
|